Hematology Device Classification Codes

GKZ Class 2

Counter, Differential Cell

Clearances 375

Regulation 21 CFR 864.5220

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KIT Class 1

Media And Components, Synthetic Cell And Tissue Culture

Clearances 367

Regulation 21 CFR 864.2220

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LCP Class 2

Assay, Glycosylated Hemoglobin

Clearances 238

Regulation 21 CFR 864.7470

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JPK Class 2

Mixture, Hematology Quality Control

Clearances 190

Regulation 21 CFR 864.8625

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GGP Class 2

Test, Qualitative And Quantitative Factor Deficiency

Clearances 189

Regulation 21 CFR 864.7290

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JPA Class 2

System, Multipurpose For In Vitro Coagulation Studies

Clearances 179

Regulation 21 CFR 864.5425

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KIR Class 1

Cells, Animal And Human, Cultured

Clearances 170

Regulation 21 CFR 864.2280

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GKL Class 2

Counter, Cell, Automated (Particle Counter)

Clearances 130

Regulation 21 CFR 864.5200

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GJS Class 2

Test, Time, Prothrombin

Clearances 126

Regulation 21 CFR 864.7750

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GGN Class 2

Plasma, Coagulation Control

Clearances 97

Regulation 21 CFR 864.5425

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KHE Class 2

Reagent, Occult Blood

Clearances 96

Regulation 21 CFR 864.6550

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GJT Class 2

Plasma, Coagulation Factor Deficient

Clearances 79

Regulation 21 CFR 864.7290

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DAP Class 2

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Clearances 56

Regulation 21 CFR 864.7320

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JBQ Class 2

Antithrombin Iii Quantitation

Clearances 56

Regulation 21 CFR 864.7060

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GFO Class 2

Activated Partial Thromboplastin

Clearances 52

Regulation 21 CFR 864.7925

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GKP Class 2

Instrument, Coagulation, Automated

Clearances 48

Regulation 21 CFR 864.5400

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KFF Class 2

Assay, Heparin

Clearances 47

Regulation 21 CFR 864.7525

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KIS Class 1

Sera, Animal And Human

Clearances 45

Regulation 21 CFR 864.2800

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GGC Class 2

Control, Plasma, Abnormal

Clearances 40

Regulation 21 CFR 864.5425

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JTS Class 1

Stains, Microbiologic

Clearances 40

Regulation 21 CFR 864.1850

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GKR Class 2

System, Hemoglobin, Automated

Clearances 39

Regulation 21 CFR 864.5620

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KHG Class 2

Whole Blood Hemoglobin Determination

Clearances 39

Regulation 21 CFR 864.7500

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GIF Class 1

Diluent, Blood Cell

Clearances 38

Regulation 21 CFR 864.8200

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JOZ Class 2

System, Automated Platelet Aggregation

Clearances 36

Regulation 21 CFR 864.5700

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JOY Class 2

Device, Automated Cell-Locating

Clearances 35

Regulation 21 CFR 864.5260

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IAF Class 1

Wright'S Stain

Clearances 33

Regulation 21 CFR 864.1850

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GGW Class 2

Test, Time, Partial Thromboplastin

Clearances 32

Regulation 21 CFR 864.7925

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GGK Class 1

Products, Red-Cell Lysing Products

Clearances 29

Regulation 21 CFR 864.8540

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GHH Class 2

Fibrin Split Products

Clearances 28

Regulation 21 CFR 864.7320

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KQJ Class 2

System, Fibrinogen Determination

Clearances 28

Regulation 21 CFR 864.7340

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POV Class 2

Semen Analysis Device

Clearances 28

Regulation 21 CFR 864.5220

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JBD Class 2

System, Analysis, Electrophoretic Hemoglobin

Clearances 26

Regulation 21 CFR 864.7440

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KRZ Class 2

Calibrator For Hemoglobin And Hematocrit Measurement

Clearances 25

Regulation 21 CFR 864.8165

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JBP Class 2

Activated Whole Blood Clotting Time

Clearances 24

Regulation 21 CFR 864.7140

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GKA Class 2

Abnormal Hemoglobin Quantitation

Clearances 23

Regulation 21 CFR 864.7415

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GIO Class 1

Tube, Collection, Capillary Blood

Clearances 22

Regulation 21 CFR 864.6150

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GGT Class 2

Assay, Erythropoietin

Clearances 20

Regulation 21 CFR 864.7250

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GIZ Class 2

Plasma, Control, Normal

Clearances 20

Regulation 21 CFR 864.5425

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GJA Class 2

Test, Thrombin Time

Clearances 20

Regulation 21 CFR 864.7875

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GHM Class 2

Test, Sickle Cell

Clearances 18

Regulation 21 CFR 864.7825

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KIP Class 1

Formulations, Balanced Salt Solutions

Clearances 17

Regulation 21 CFR 864.2875

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KSR Class 2

Container, Empty, For Collection & Processing Of Blood & Blood Components

Clearances 16

Regulation 21 CFR 864.9100

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LED Class 1

Stains, Chemical Solution

Clearances 16

Regulation 21 CFR 864.1850

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GGM Class 2

Control, Hemoglobin

Clearances 15

Regulation 21 CFR 864.8625

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GKF Class 2

Instrument, Hematocrit, Automated

Clearances 15

Regulation 21 CFR 864.5600

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HZJ Class 1

Stain, Papanicolau

Clearances 15

Regulation 21 CFR 864.1850

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JOX Class 2

Analyzer, Heparin, Automated

Clearances 15

Regulation 21 CFR 864.5680

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JPI Class 2

Device, Hematocrit Measuring

Clearances 15

Regulation 21 CFR 864.6400

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LKM Class 2

Counter, Urine Particle

Clearances 15

Regulation 21 CFR 864.5200

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BSB Class 2

Warmer, Blood, Non-Electromagnetic Radiation

Clearances 14

Regulation 21 CFR 864.9205

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GIR Class 1

Reagent, Russel Viper Venom

Clearances 14

Regulation 21 CFR 864.8950

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GKH Class 1

Apparatus, Automated Blood Cell Diluting

Clearances 14

Regulation 21 CFR 864.5240

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HYJ Class 1

Hematoxylin

Clearances 14

Regulation 21 CFR 864.1850

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KQG Class 2

Instrument, Coagulation

Clearances 14

Regulation 21 CFR 864.5400

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KRX Class 2

Calibrator For Cell Indices

Clearances 14

Regulation 21 CFR 864.8150

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GIS Class 2

Test, Fibrinogen

Clearances 13

Regulation 21 CFR 864.7340

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JPD Class 2

Hemoglobin A2 Quantitation

Clearances 13

Regulation 21 CFR 864.7400

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KJA Class 1

Flask, Tissue Culture

Clearances 13

Regulation 21 CFR 864.2240

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KSG Class 2

Media, Potentiating For In Vitro Diagnostic Use

Clearances 13

Regulation 21 CFR 864.9600

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LCO Class 2

Platelet Factor 4 Radioimmunoassay

Clearances 13

Regulation 21 CFR 864.7695

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MXZ Class 2

Immunohistochemistry Assay, Antibody, Progesterone Receptor

Clearances 13

Regulation 21 CFR 864.1860

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NQN Class 2

Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

Clearances 13

Regulation 21 CFR 864.1860

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JBX Class 2

Aggregrometer, Platelet

Clearances 12

Regulation 21 CFR 864.6675

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JCF Class 1

Lymphocyte Separation Medium

Clearances 12

Regulation 21 CFR 864.8500

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JCM Class 2

Control, Hemoglobin, Abnormal

Clearances 12

Regulation 21 CFR 864.7415

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JCN Class 2

Control, Cell Counter, Normal And Abnormal

Clearances 12

Regulation 21 CFR 864.8625

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KSF Class 2

Kit, Quality Control For Blood Banking Reagents

Clearances 12

Regulation 21 CFR 864.9650

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NOT Class 2

Microscope, Automated, Image Analysis, Operator Intervention

Clearances 12

Regulation 21 CFR 864.1860

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GHR Class 2

Reagent, Platelet Aggregation

Clearances 11

Regulation 21 CFR 864.5700

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GKG Class 2

Centrifuge, Hematocrit

Clearances 11

Regulation 21 CFR 864.6400

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JIO Class 2

Blood, Occult, Colorimetric, In Urine

Clearances 11

Regulation 21 CFR 864.6550

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LNJ Class 2

Analyzer, Chromosome, Automated

Clearances 11

Regulation 21 CFR 864.5260

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MYA Class 2

Immunohistochemistry Antibody Assay, Estrogen Receptor

Clearances 11

Regulation 21 CFR 864.1860

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GKT Class 2

Separator, Automated, Blood Cell, Diagnostic

Clearances 10

Regulation 21 CFR 864.9245

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GLQ Class 2

Mixture, Control, White-Cell And Red-Cell Indices

Clearances 10

Regulation 21 CFR 864.8625

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HYB Class 1

Eosin Y

Clearances 10

Regulation 21 CFR 864.1850

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KQC Class 1

Stains, Hematology

Clearances 9

Regulation 21 CFR 864.1850

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GGL Class 2

Control, White-Cell

Clearances 8

Regulation 21 CFR 864.8625

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GIL Class 2

Plasma, Fibrinogen Control

Clearances 8

Regulation 21 CFR 864.7340

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KIZ Class 1

Dish, Tissue Culture

Clearances 8

Regulation 21 CFR 864.2240

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KRY Class 2

Calibrator For Platelet Counting

Clearances 8

Regulation 21 CFR 864.8175

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KSA Class 2

Calibrator For Red-Cell And White-Cell Counting

Clearances 8

Regulation 21 CFR 864.8185

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KSQ Class 1

Device, Blood Mixing And Blood Weighing

Clearances 8

Regulation 21 CFR 864.9195

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KSX Class 2

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Clearances 8

Regulation 21 CFR 864.9160

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GKK Class 2

Cyanomethemoglobin

Clearances 7

Regulation 21 CFR 864.7500

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GLK Class 2

Control, Hematocrit

Clearances 7

Regulation 21 CFR 864.8625

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HYK Class 1

Hematoxylin Harris'S

Clearances 7

Regulation 21 CFR 864.1850

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JCA Class 2

Device, Bleeding Time

Clearances 7

Regulation 21 CFR 864.6100

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JCO Class 2

Bothrops Atrox Reagent

Clearances 7

Regulation 21 CFR 864.8100

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JPH Class 1

Test, Erythrocyte Sedimentation Rate

Clearances 7

Regulation 21 CFR 864.6700

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KFC Class 1

Methylene Blue, Tissue Stain

Clearances 7

Regulation 21 CFR 864.1850

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LIZ Class 2

Assay, T Lymphocyte Surface Marker

Clearances 7

Regulation 21 CFR 864.5220

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LJX Class 1

Test, Urine Leukocyte

Clearances 7

Regulation 21 CFR 864.7675

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QFR Class 2

Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

Clearances 7

Regulation 21 CFR 864.5430

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GKJ Class 1

Spinner, Slide, Automated

Clearances 6

Regulation 21 CFR 864.5850

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HYI Class 1

Iodine, Grams

Clearances 6

Regulation 21 CFR 864.1850

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KSB Class 2

Set, Transfer (Blood/Plasma)

Clearances 6

Regulation 21 CFR 864.9875

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KSS Class 1

Supplies, Blood-Bank

Clearances 6

Regulation 21 CFR 864.9050

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MIF Class 2

Prothrombin Fragment 1.2

Clearances 6

Regulation 21 CFR 864.7320

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OYE Class 2

Flow Cytometric Reagents And Accessories.

Clearances 6

Regulation 21 CFR 864.5220

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GHS Class 2

Assay, Carboxyhemoglobin

Clearances 5

Regulation 21 CFR 864.7425

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GJR Class 2

Control, Red-Cell

Clearances 5

Regulation 21 CFR 864.8625

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GLY Class 2

Oximeter To Measure Hemoglobin

Clearances 5

Regulation 21 CFR 864.7500

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HZT Class 1

Reagent, Schiff

Clearances 5

Regulation 21 CFR 864.1850

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ICF Class 1

Crystal Violet For Histology

Clearances 5

Regulation 21 CFR 864.1850

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JBF Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Clearances 5

Regulation 21 CFR 864.7360

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KSK Class 2

Solution, Stabilized Enzyme

Clearances 5

Regulation 21 CFR 864.9400

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LGO Class 1

Test, Leukocyte Typing

Clearances 5

Regulation 21 CFR 864.7675

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LGP Class 2

Assay, Alpha-2-Antiplasmin

Clearances 5

Regulation 21 CFR 864.5425

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NPQ Class 2

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Clearances 5

Regulation 21 CFR 864.7280

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NPR Class 2

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Clearances 5

Regulation 21 CFR 864.7280

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OOX Class 2

Automated Occult Blood Analyzer

Clearances 5

Regulation 21 CFR 864.6550

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DDQ Class 2

Antigen, Antiserum, Control, Antithrombin Iii

Clearances 4

Regulation 21 CFR 864.7060

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GHD Class 1

Test, Leukocyte Alkaline Phosphatase

Clearances 4

Regulation 21 CFR 864.7660

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GIT Class 2

Reagent & Control, Partial Thromboplastin Time

Clearances 4

Regulation 21 CFR 864.7925

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GJG Class 1

Pipette, Quantitative, Hematology

Clearances 4

Regulation 21 CFR 864.6160

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GJP Class 2

Control, Platelet

Clearances 4

Regulation 21 CFR 864.8625

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GJW Class 1

Pipette, Pasteur

Clearances 4

Regulation 21 CFR 864.6160

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GKM Class 1

Hand-Tally, Differential

Clearances 4

Regulation 21 CFR 864.6160

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HYF Class 1

Giemsa Stain

Clearances 4

Regulation 21 CFR 864.1850

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HZH Class 1

Orange G

Clearances 4

Regulation 21 CFR 864.1850

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ICL Class 1

Carbol Fuchsin

Clearances 4

Regulation 21 CFR 864.1850

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IDC Class 1

Acridine Orange

Clearances 4

Regulation 21 CFR 864.1850

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KJF Class 1

System, Suspension, Cell Culture

Clearances 4

Regulation 21 CFR 864.2240

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KPB Class 1

Media And Components, Mycoplasma Detection

Clearances 4

Regulation 21 CFR 864.2360

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KQI Class 2

Assay, Fetal Hemoglobin

Clearances 4

Regulation 21 CFR 864.7455

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KSE Class 2

Refrigerator, Freezer, Blood Storage

Clearances 4

Regulation 21 CFR 864.9700

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KSI Class 2

Lectins And Protectins

Clearances 4

Regulation 21 CFR 864.9550

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KSZ Class 2

System, Test, Automated Blood Grouping And Antibody

Clearances 4

Regulation 21 CFR 864.9175

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KZL Class 2

Device, Warming. Blood And Plasma

Clearances 4

Regulation 21 CFR 864.9205

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OEO Class 2

Automated Digital Image Manual Interpretation Microscope

Clearances 4

Regulation 21 CFR 864.1860

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GFX Class 2

Fibrinogen Standard

Clearances 3

Regulation 21 CFR 864.7340

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GIA Class 1

Test, Leukocyte Peroxidase

Clearances 3

Regulation 21 CFR 864.7675

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GIG Class 2

Hemoglobinometer

Clearances 3

Regulation 21 CFR 864.7500

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GIQ Class 2

Hemoglobin S

Clearances 3

Regulation 21 CFR 864.7415

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GKN Class 2

Timer, Clot, Automated

Clearances 3

Regulation 21 CFR 864.5400

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GLG Class 1

Platelet Counting, Manual

Clearances 3

Regulation 21 CFR 864.6160

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JBR Class 2

Test, Heparin Neutralization

Clearances 3

Regulation 21 CFR 864.7525

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JBZ Class 2

Study, Platelet Adhesive

Clearances 3

Regulation 21 CFR 864.6650

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JPJ Class 2

Red-Cell Indices, Calculated

Clearances 3

Regulation 21 CFR 864.5300

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JWO Class 2

Device, Blood Volume Measuring

Clearances 3

Regulation 21 CFR 864.5950

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KJB Class 1

Apparatus, Roller

Clearances 3

Regulation 21 CFR 864.2240

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KJC Class 1

Bottle, Roller, Tissue Culture

Clearances 3

Regulation 21 CFR 864.2240

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KJH Class 1

Apparatus, Perfusion

Clearances 3

Regulation 21 CFR 864.2240

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KJR Class 1

Erythrosin B

Clearances 3

Regulation 21 CFR 864.1850

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NRF Class 2

Material, Quality Control, Semen Analysis

Clearances 3

Regulation 21 CFR 864.8625

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DAT Class 2

Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

Clearances 2

Regulation 21 CFR 864.7340

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GFT Class 2

Protamine Sulphate

Clearances 2

Regulation 21 CFR 864.7525

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GGQ Class 2

Test, Prothrombin Consumption

Clearances 2

Regulation 21 CFR 864.7720

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GGX Class 1

Pipette, Sahli

Clearances 2

Regulation 21 CFR 864.6160

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GGZ Class 2

Oxyhemoglobin

Clearances 2

Regulation 21 CFR 864.7500

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GHO Class 1

Hemocytometer

Clearances 2

Regulation 21 CFR 864.6160

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GHQ Class 2

Stain, Fetal Hemoglobin

Clearances 2

Regulation 21 CFR 864.7455

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GHY Class 2

Hematocrit, Tube, Rack, Sealer, Holder

Clearances 2

Regulation 21 CFR 864.6400

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GIE Class 2

Fibrometer

Clearances 2

Regulation 21 CFR 864.5400

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GJZ Class 2

Cyanomethemoglobin Reagent And Standard Solution

Clearances 2

Regulation 21 CFR 864.7500

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GKB Class 1

Device, Automated Sedimentation Rate

Clearances 2

Regulation 21 CFR 864.5800

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GKX Class 2

Instrument, Automated Platelet Counting

Clearances 2

Regulation 21 CFR 864.5200

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HYW Class 1

Stain, Trichrome, Mallory'S

Clearances 2

Regulation 21 CFR 864.1850

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HZA Class 1

Methyl Green

Clearances 2

Regulation 21 CFR 864.1850

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HZC Class 1

Mucicarmine

Clearances 2

Regulation 21 CFR 864.1850

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HZZ Class 1

Sudan Black B

Clearances 2

Regulation 21 CFR 864.1850

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ICN Class 1

Biebrich Scarlet

Clearances 2

Regulation 21 CFR 864.1850

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IDA Class 1

Alcian Blue

Clearances 2

Regulation 21 CFR 864.1850

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JBB Class 2

Solubility, Hemoglobin, Abnormal

Clearances 2

Regulation 21 CFR 864.7825

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JBL Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

Clearances 2

Regulation 21 CFR 864.7360

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JBN Class 2

Fibrin Monomer Paracoagulation

Clearances 2

Regulation 21 CFR 864.7300

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JBY Class 2

Aggregometer, Platelet, Photo-Optical Scanning

Clearances 2

Regulation 21 CFR 864.6675

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KIW Class 1

Kit, Mycoplasma Detection

Clearances 2

Regulation 21 CFR 864.2360

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KJK Class 1

Auramine O

Clearances 2

Regulation 21 CFR 864.1850

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KSL Class 1

Solution, Copper Sulfate For Specific Gravity Determinations

Clearances 2

Regulation 21 CFR 864.9320

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LGL Class 2

Assay, Bart'S, Hemoglobin

Clearances 2

Regulation 21 CFR 864.7500

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LIM Class 2

Test, Screening, For D Positive Fetal Rbc'S

Clearances 2

Regulation 21 CFR 864.7455

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LKZ Class 2

Red-Cell Count By Photometry

Clearances 2

Regulation 21 CFR 864.7100

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LLG Class 2

Kit, Igg, Platelet Associated

Clearances 2

Regulation 21 CFR 864.5425

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NID Class 2

Assay, Proliferation, In Vitro, T Lymphocyte

Clearances 2

Regulation 21 CFR 864.5220

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NJW Class 2

Control Material, Her-2/Neu, Immunohistochemistry

Clearances 2

Regulation 21 CFR 864.1860

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NOZ Class 2

Assay, 1,5-Anhydroglucitol (15ag)

Clearances 2

Regulation 21 CFR 864.7470

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OMM Class 2

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Clearances 2

Regulation 21 CFR 864.7280

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QLU Class 2

Anti-Factor Xa Activity Test System, Apixaban

Clearances 2

Regulation 21 CFR 864.7295

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GFK Class 2

Fibrinogen Determination Standards And Controls

Clearances 1

Regulation 21 CFR 864.7340

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GFS Class 2

Standards And Controls, Hemoglobin, Normal And Abnormal

Clearances 1

Regulation 21 CFR 864.8625

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GGG Class 2

Guaiac Reagent

Clearances 1

Regulation 21 CFR 864.6550

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GGH Class 1

Iron Stains

Clearances 1

Regulation 21 CFR 864.1850

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GGJ Class 1

Fluid, Diluting, White-Cell

Clearances 1

Regulation 21 CFR 864.8200

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GGO Class 2

Reagent, Thromboplastin And Control

Clearances 1

Regulation 21 CFR 864.7925

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GHC Class 1

Tube, Sedimentation Rate

Clearances 1

Regulation 21 CFR 864.6700

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GJB Class 2

Thrombin

Clearances 1

Regulation 21 CFR 864.7875

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GJH Class 1

Stain, Reticulocyte

Clearances 1

Regulation 21 CFR 864.1850

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GJL Class 1

Romanowsky Stains

Clearances 1

Regulation 21 CFR 864.1850

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GKQ Class 1

Test, Thromboplastin Generation

Clearances 1

Regulation 21 CFR 864.7900

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HYC Class 1

Fast Green

Clearances 1

Regulation 21 CFR 864.1850

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HYD Class 1

Fast Red Salt B

Clearances 1

Regulation 21 CFR 864.1850

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HYG Class 1

Glenner'S Stain

Clearances 1

Regulation 21 CFR 864.1850

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HYO Class 1

Hematoxylin Weigert'S

Clearances 1

Regulation 21 CFR 864.1850

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HYS Class 1

Light Green

Clearances 1

Regulation 21 CFR 864.1850

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HZG Class 1

Oil Red O

Clearances 1

Regulation 21 CFR 864.1850

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HZL Class 1

Phloxine B

Clearances 1

Regulation 21 CFR 864.1850

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HZO Class 1

Stain, Ponceau

Clearances 1

Regulation 21 CFR 864.1850

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HZS Class 1

Safranin

Clearances 1

Regulation 21 CFR 864.1850

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IAB Class 1

Toluidine Blue

Clearances 1

Regulation 21 CFR 864.1850

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IAC Class 1

Van Gieson'S Stain

Clearances 1

Regulation 21 CFR 864.1850

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IAE Class 1

Hematoxylin, Iron, Weigert'S

Clearances 1

Regulation 21 CFR 864.1850

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ICC Class 1

Eosin B

Clearances 1

Regulation 21 CFR 864.1850

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ICH Class 1

Congo Red

Clearances 1

Regulation 21 CFR 864.1850

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ICJ Class 1

Carbol Night Blue

Clearances 1

Regulation 21 CFR 864.1850

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ICX Class 1

Aniline

Clearances 1

Regulation 21 CFR 864.1850

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IDF Class 1

Acid, Fuchsin

Clearances 1

Regulation 21 CFR 864.1850

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JBE Class 2

Cell Enzymes (Erythrocytic And Leukocytic)

Clearances 1

Regulation 21 CFR 864.7100

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JBO Class 2

Test, Euglobulin Lysis

Clearances 1

Regulation 21 CFR 864.7275

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JCG Class 1

Fluid, Diluting, Manual Cell

Clearances 1

Regulation 21 CFR 864.8200

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JLM Class 2

Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase

Clearances 1

Regulation 21 CFR 864.7360

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JMB Class 2

Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase

Clearances 1

Regulation 21 CFR 864.7360

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JPC Class 2

Hemoglobin F Quantitation

Clearances 1

Regulation 21 CFR 864.7455

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JPE Class 2

Antithrombin Iii, Two Stage Clotting Time Assay

Clearances 1

Regulation 21 CFR 864.7060

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KFD Class 1

Aniline Blue

Clearances 1

Regulation 21 CFR 864.1850

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KFE Class 1

Neutral Red

Clearances 1

Regulation 21 CFR 864.1850

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KIQ Class 1

Kit, Culture, Chromosome

Clearances 1

Regulation 21 CFR 864.2260

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KIY Class 1

Chamber, Slide Culture

Clearances 1

Regulation 21 CFR 864.2240

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KJN Class 1

Brilliant Cresyl Blue

Clearances 1

Regulation 21 CFR 864.1850

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KJX Class 1

Jenner Stain

Clearances 1

Regulation 21 CFR 864.1850

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KJY Class 1

Malachite Green

Clearances 1

Regulation 21 CFR 864.1850

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KKJ Class 1

Sudan Iii

Clearances 1

Regulation 21 CFR 864.1850

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KKK Class 1

Sudan Iv

Clearances 1

Regulation 21 CFR 864.1850

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KQE Class 2

Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase

Clearances 1

Regulation 21 CFR 864.7360

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KQH Class 2

Red-Cell Indices

Clearances 1

Regulation 21 CFR 864.5300

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KSD Class 1

Device, Heat-Sealing

Clearances 1

Regulation 21 CFR 864.9750

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KSN Class 2

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

Clearances 1

Regulation 21 CFR 864.9285

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KSO Class 1

Centrifuge, Blood-Bank For In Vitro Diagnostic Use

Clearances 1

Regulation 21 CFR 864.9275

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KSP Class 1

Apparatus, Cell-Freezing And Reagents

Clearances 1

Regulation 21 CFR 864.9225

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KSW Class 2

System, Processing For Frozen Blood

Clearances 1

Regulation 21 CFR 864.9145

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KSY Class 1

Boxes, View, Blood Grouping

Clearances 1

Regulation 21 CFR 864.9185

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LEE Class 1

Stains, Dye Solution

Clearances 1

Regulation 21 CFR 864.1850

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LEF Class 1

Stains, Dye Powder

Clearances 1

Regulation 21 CFR 864.1850

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LGY Class 1

Trypan Blue

Clearances 1

Regulation 21 CFR 864.1850

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LJD Class 2

Assay, B Lymphocyte Marker

Clearances 1

Regulation 21 CFR 864.5220

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MAM Class 2

Dna-Probe, B And T Lymphocyte

Clearances 1

Regulation 21 CFR 864.5220

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MLL Class 2

Hemoglobin C (Abnormal Hemoglobin Variant)

Clearances 1

Regulation 21 CFR 864.7415

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NBK Class 2

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Clearances 1

Regulation 21 CFR 864.1860

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NRS Class 2

Control Material, Blood Circulating Epithelial Cancer Cell

Clearances 1

Regulation 21 CFR 864.8625

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NTR Class 1

Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Clearances 1

Regulation 21 CFR 864.1860

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OBW Class 2

11-Dehydro Thromboxane B2 Kit, Urinary

Clearances 1

Regulation 21 CFR 864.5700

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ODV Class 2

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Clearances 1

Regulation 21 CFR 864.7750

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OSL Class 2

Control, Fecal Occult Blood

Clearances 1

Regulation 21 CFR 864.6550

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PFG Class 2

Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

Clearances 1

Regulation 21 CFR 864.1870

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PWD Class 2

Flow Cytometric Test System For Hematopoietic Neoplasms

Clearances 1

Regulation 21 CFR 864.7010

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BSA Class 3

Warmer, Blood, Electromagnetic Radiation

Clearances 0

Regulation 21 CFR 864.9205

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DAR Class 2

Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 864.7340

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DAX Class 2

Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 864.7340

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DAZ Class 2

Fibrinogen And Split Products, Antigen, Antiserum, Control

Clearances 0

Regulation 21 CFR 864.7340

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GGF Class 2

Acid Hematin

Clearances 0

Regulation 21 CFR 864.7500

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GGY Class 1

Pipette, Diluting

Clearances 0

Regulation 21 CFR 864.6160

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GHA Class 2

Hemoglobin, Alkali Resistant

Clearances 0

Regulation 21 CFR 864.7455

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GHK Class 1

Centrifuge, Microsedimentation

Clearances 0

Regulation 21 CFR 864.5350

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GHZ Class 1

Solution, Gugol Blue

Clearances 0

Regulation 21 CFR 864.1850

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GII Class 2

Glutathione, Red-Cell

Clearances 0

Regulation 21 CFR 864.7375

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GJC Class 2

Assay, Sulfhemoglobin

Clearances 0

Regulation 21 CFR 864.7490

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GJJ Class 1

Stains, Heinz Body

Clearances 0

Regulation 21 CFR 864.1850

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GJN Class 1

Fluid, Diluting, Red-Cell

Clearances 0

Regulation 21 CFR 864.8200

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GKE Class 1

Osmotic Fragility Testing

Clearances 0

Regulation 21 CFR 864.6600

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GKW Class 2

Aggregometer, Platelet, Thrombokinetogram

Clearances 0

Regulation 21 CFR 864.6675

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HYE Class 1

Solution, Fontanna Silver

Clearances 0

Regulation 21 CFR 864.1850

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HYH Class 1

Gold Chloride

Clearances 0

Regulation 21 CFR 864.1850

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HYL Class 1

Hematoxylin Mayer'S

Clearances 0

Regulation 21 CFR 864.1850

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HYQ Class 1

Iron Chloride-Weigert

Clearances 0

Regulation 21 CFR 864.1850

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HYR Class 1

Leuco-Patent Blue

Clearances 0

Regulation 21 CFR 864.1850

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HYT Class 1

Luxol Fast Blue

Clearances 0

Regulation 21 CFR 864.1850

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HYY Class 1

Metanil Yellow

Clearances 0

Regulation 21 CFR 864.1850

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HYZ Class 1

Methenamine Silver

Clearances 0

Regulation 21 CFR 864.1850

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HZD Class 1

Muller'S Colloidal Iron

Clearances 0

Regulation 21 CFR 864.1850

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HZE Class 1

Nile Blue

Clearances 0

Regulation 21 CFR 864.1850

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HZF Class 1

Nuclear Fast Red

Clearances 0

Regulation 21 CFR 864.1850

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HZM Class 1

Hematoxylin, Acid, Phosphotungstic

Clearances 0

Regulation 21 CFR 864.1850

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HZN Class 1

Picro Methyl Blue

Clearances 0

Regulation 21 CFR 864.1850

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HZP Class 1

Pyronin

Clearances 0

Regulation 21 CFR 864.1850

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HZQ Class 1

Red-Violet Lb

Clearances 0

Regulation 21 CFR 864.1850

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HZR Class 1

Resorcin Fuchsin

Clearances 0

Regulation 21 CFR 864.1850

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HZX Class 1

Silver Nitrate

Clearances 0

Regulation 21 CFR 864.1850

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HZY Class 1

Sirius Red

Clearances 0

Regulation 21 CFR 864.1850

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IAA Class 1

Titan Yellow

Clearances 0

Regulation 21 CFR 864.1850

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IAD Class 1

Van Gieson'S Picro-Fuchsin

Clearances 0

Regulation 21 CFR 864.1850

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ICD Class 1

Darrow Red

Clearances 0

Regulation 21 CFR 864.1850

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ICG Class 1

Cresyl Violet Acetate

Clearances 0

Regulation 21 CFR 864.1850

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ICI Class 1

Hematoxylin, Chrome Alum

Clearances 0

Regulation 21 CFR 864.1850

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ICM Class 1

Brilliant Yellow

Clearances 0

Regulation 21 CFR 864.1850

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ICO Class 1

Best'S Carmine

Clearances 0

Regulation 21 CFR 864.1850

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ICQ Class 1

Azure A

Clearances 0

Regulation 21 CFR 864.1850

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ICR Class 1

Azocarmine B

Clearances 0

Regulation 21 CFR 864.1850

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ICS Class 1

Azocarmine G

Clearances 0

Regulation 21 CFR 864.1850

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ICT Class 1

Azan Counterstain

Clearances 0

Regulation 21 CFR 864.1850

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ICY Class 1

Acid, Aniline, Fuchsin

Clearances 0

Regulation 21 CFR 864.1850

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ICZ Class 1

Ammoniacal Silver Hydroxide Silver Nitrate

Clearances 0

Regulation 21 CFR 864.1850

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IDB Class 1

Aldehyde Fuchsin

Clearances 0

Regulation 21 CFR 864.1850

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IDD Class 1

Alizarin Red

Clearances 0

Regulation 21 CFR 864.1850

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IDE Class 1

Acid, Hematein

Clearances 0

Regulation 21 CFR 864.1850

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JBG Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot

Clearances 0

Regulation 21 CFR 864.7360

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JBH Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod

Clearances 0

Regulation 21 CFR 864.7360

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JBI Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition

Clearances 0

Regulation 21 CFR 864.7360

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JBJ Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction

Clearances 0

Regulation 21 CFR 864.7360

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JBK Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic

Clearances 0

Regulation 21 CFR 864.7360

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JBM Class 2

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis

Clearances 0

Regulation 21 CFR 864.7360

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JBT Class 2

Timer, Coagulation

Clearances 0

Regulation 21 CFR 864.5400

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JBW Class 2

Red-Cell Indices, Measured

Clearances 0

Regulation 21 CFR 864.5300

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JCH Class 1

Esterase

Clearances 0

Regulation 21 CFR 864.1850

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JCI Class 1

Acid Phosphatase, Cytochemical

Clearances 0

Regulation 21 CFR 864.1850

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JCJ Class 1

Alkaline Phosphatase

Clearances 0

Regulation 21 CFR 864.7660

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JIP Class 2

Blood, Occult, Enzymatic Method, In Urine

Clearances 0

Regulation 21 CFR 864.6550

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JMC Class 2

Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase

Clearances 0

Regulation 21 CFR 864.7360

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JMH Class 2

Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase

Clearances 0

Regulation 21 CFR 864.7375

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JPB Class 2

Hemoglobin M

Clearances 0

Regulation 21 CFR 864.7415

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JPF Class 2

Prothrombin-Proconvertin And Thrombotest

Clearances 0

Regulation 21 CFR 864.7735

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JWR Class 1

Atp Release (Luminescence)

Clearances 0

Regulation 21 CFR 864.7040

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KHF Class 1

Adenine Nucleotide Quantitation

Clearances 0

Regulation 21 CFR 864.7040

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KIX Class 1

Media, Mycoplasma Detection

Clearances 0

Regulation 21 CFR 864.2360

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KJD Class 1

Spinner, Flask

Clearances 0

Regulation 21 CFR 864.2240

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KJE Class 1

Spinner System, Cell Culture

Clearances 0

Regulation 21 CFR 864.2240

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KJL Class 1

Azure C

Clearances 0

Regulation 21 CFR 864.1850

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KJM Class 1

Bismarck Brown Y

Clearances 0

Regulation 21 CFR 864.1850

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KJO Class 1

Brilliant Green

Clearances 0

Regulation 21 CFR 864.1850

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KJP Class 1

Carmine

Clearances 0

Regulation 21 CFR 864.1850

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KJQ Class 1

Chlorazol Black E

Clearances 0

Regulation 21 CFR 864.1850

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KJS Class 1

Ethyl Eosin

Clearances 0

Regulation 21 CFR 864.1850

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KJT Class 1

Indigocarmine

Clearances 0

Regulation 21 CFR 864.1850

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KJW Class 1

Janus Green B

Clearances 0

Regulation 21 CFR 864.1850

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KJZ Class 1

Martius Yellow

Clearances 0

Regulation 21 CFR 864.1850

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KKA Class 1

Methyl Orange

Clearances 0

Regulation 21 CFR 864.1850

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KKB Class 1

Methyl Violet 2b

Clearances 0

Regulation 21 CFR 864.1850

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KKC Class 1

Methylene Violet

Clearances 0

Regulation 21 CFR 864.1850

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KKD Class 1

Nigrosin

Clearances 0

Regulation 21 CFR 864.1850

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KKE Class 1

Orange Ii

Clearances 0

Regulation 21 CFR 864.1850

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KKF Class 1

Orcein

Clearances 0

Regulation 21 CFR 864.1850

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KKG Class 1

Protargol S

Clearances 0

Regulation 21 CFR 864.1850

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KKH Class 1

Tablet, Resazurin

Clearances 0

Regulation 21 CFR 864.1850

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KKI Class 1

Rose Bengal

Clearances 0

Regulation 21 CFR 864.1850

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KKL Class 1

Thionin

Clearances 0

Regulation 21 CFR 864.1850

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KKM Class 1

Methylene Blue Thiocyanate

Clearances 0

Regulation 21 CFR 864.1850

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KKP Class 1

Solution, Silver Carbonate

Clearances 0

Regulation 21 CFR 864.1850

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KKQ Class 1

Sodium Periodate

Clearances 0

Regulation 21 CFR 864.1850

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KKR Class 1

Potassium Periodate

Clearances 0

Regulation 21 CFR 864.1850

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KKS Class 1

Acid, Periodic

Clearances 0

Regulation 21 CFR 864.1850

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KKT Class 1

Hematoxylin, Ehrlich'S

Clearances 0

Regulation 21 CFR 864.1850

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KKW Class 1

Basic Fuchsin

Clearances 0

Regulation 21 CFR 864.1850

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KQF Class 2

Assay, Glutathione Reductase

Clearances 0

Regulation 21 CFR 864.7375

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KSH Class 2

Chamber, Environmental For The Storage Of Platelet Concentrate

Clearances 0

Regulation 21 CFR 864.9575

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KSM Class 2

System, Test, Combs, Automated

Clearances 0

Regulation 21 CFR 864.9300

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KST Class 1

System, Blood Collection, Vacuum-Assisted, Manual

Clearances 0

Regulation 21 CFR 864.9125

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LPI Class 3

Kit, Assay, Progesterone Receptor

Clearances 0

Regulation 21 CFR 864.1860

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LPJ Class 3

Kit, Assay, Estrogen Receptor

Clearances 0

Regulation 21 CFR 864.1860

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MMH Class 2

Blood Establishment Computer Software And Accessories

Clearances 0

Regulation 21 CFR 864.9165

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MYJ Class 2

Device, Mixing And Weighing, Semi-Automated

Clearances 0

Regulation 21 CFR 864.9195

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MYX Class 1

System, Blood Collection, Vacuum-Assisted, Automated

Clearances 0

Regulation 21 CFR 864.9125

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MZG Class 2

Test, Residual, Wbc In Leukoreduced Blood

Clearances 0

Regulation 21 CFR 864.8625

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NGB Class 2

Test, Glycosylated Hemoglobin, Over The Counter

Clearances 0

Regulation 21 CFR 864.7470

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NGK Class 2

Test, Occult Blood, Over The Counter

Clearances 0

Regulation 21 CFR 864.6550

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NJT Class 1

Immunohistochemistry Reagents And Kits

Clearances 0

Regulation 21 CFR 864.1860

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NKF Class 3

Immunohistochemistry Antibody Assay, C-Kit

Clearances 0

Regulation 21 CFR 864.1860

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NQF Class 3

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

Clearances 0

Regulation 21 CFR 864.1860

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NVG Class 1

Tissue Culture, Accessories, Dental

Clearances 0

Regulation 21 CFR 864.2240

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OAO Class 2

Cord Blood Processing System And Storage Container

Clearances 0

Regulation 21 CFR 864.9900

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OOF Class 2

Cryogenic Cord Blood Storage Container

Clearances 0

Regulation 21 CFR 864.9900

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OQX Class 2

Self-Contained Blood Grouping

Clearances 0

Regulation 21 CFR 864.9175

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ORG Class 2

Platelet And Plasma Separator For Bone Graft Handling

Clearances 0

Regulation 21 CFR 864.9245

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PBC Class 2

Manual Blood Grouping And Antibody Test Systems

Clearances 0

Regulation 21 CFR 864.9175

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PDO Class 2

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Clearances 0

Regulation 21 CFR 864.1870

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PDX Class 2

Flow Cytometry Calibrator

Clearances 0

Regulation 21 CFR 864.5220

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PFK Class 2

Quality Control For Molecular Immunohematology Tests

Clearances 0

Regulation 21 CFR 864.9650

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PHJ Class 2

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Clearances 0

Regulation 21 CFR 864.7280

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PKG Class 2

Bone Marrow Processing Device To Support Hematopoietic Reconstitution

Clearances 0

Regulation 21 CFR 864.9245

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PMG Class 2

Automated Multicolor Fluorescent Imaging Cytometric Analysis System

Clearances 0

Regulation 21 CFR 864.5220

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PMQ Class 2

Peripheral Blood Processing Device For Wound Management

Clearances 0

Regulation 21 CFR 864.9245

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QGU Class 2

Hemoglobin For Donor Testing

Clearances 0

Regulation 21 CFR 864.7500

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QHR Class U

Blood Grouping Reagent

Clearances 0

Regulation 21 CFR 660.20

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QHS Class U

Anti-Human Globulin

Clearances 0

Regulation 21 CFR 660.50

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QHT Class U

Reagent Red Blood Cells

Clearances 0

Regulation 21 CFR 660.30

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QKF Class 3

Immunocytochemistry Assay, P16/Ki-67

Clearances 0

Regulation 21 CFR 864.1860

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QNH Class 3

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Clearances 0

Regulation 21 CFR 864.1860

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QTY Class 2

Von Willebrand Factor Assay

Clearances 0

Regulation 21 CFR 864.7293

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QUL Class 3

Immunohistochemistry Assay, Antibody, Folr1

Clearances 0

Regulation 21 CFR 864.1860

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QYC Class 2

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

Clearances 0

Regulation 21 CFR 864.9115

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QZJ Class 3

Immunohistochemistry Assay, Antibody, Claudin 18

Clearances 0

Regulation 21 CFR 864.1860

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SAC Class 2

Adamts13 Activity Test System

Clearances 0

Regulation 21 CFR 864.7297

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SAL Class 2

Device, Automated Cell Locating, Bone Marrow

Clearances 0

Regulation 21 CFR 864.5261

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SBL Class 3

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

Clearances 0

Regulation 21 CFR 864.1860

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SDP Class 2

Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

Clearances 0

Regulation 21 CFR 864.1861

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SER Class 3

Immunohistochemistry Assay, Antibody, Met

Clearances 0

Regulation 21 CFR 864.1860

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SES Class 2

Non-Factor Replacement Product Test System

Clearances 0

Regulation 21 CFR 864.7298

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SFS Class 2

Revumenib Eligibility Detection System

Clearances 0

Regulation 21 CFR 864.1885

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