Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

FDA product code DHN · 107 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5100
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2022-04-29

DHN 2022-04-29

Zeus IFA ANA HEp-2 Test System, Zeus dIFine

Applicant Zeus Scientific, Inc.

K number K201956

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DHN 2018-06-05

ImmuGlo HEp-2 Elite IFA

Applicant Immco Diagnostics, Inc.

K number K172745

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DHN 2016-07-28

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

Applicant Aesku Systems GmbH&Co.Kg

K number K153117

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DHN 2016-06-17

Image Navigator by Immuno Concepts

Applicant Immuno Concepts, N.A. , Ltd.

K number K160265

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DHN 2012-10-15

AESKUSLIDES ANA HEP-2

Applicant Aesku Diagnostics

K number K120889

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DHN 2007-05-22

EUROIMMUN ANA IFA: HEP-20-10

Applicant Euroimmun Us, LLC

K number K070763

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DHN 2004-11-19

RHIGENE HEP-ANA TEST SYSTEM

Applicant Corgenix, Inc.

K number K042680

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DHN 2003-01-17

LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130

Applicant Bio-Rad

K number K024220

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DHN 2003-01-15

LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131

Applicant Bio-Rad

K number K024230

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DHN 2003-01-15

LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111

Applicant Bio-Rad

K number K024229

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DHN 2003-01-15

LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127

Applicant Bio-Rad

K number K024227

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DHN 2003-01-15

LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119

Applicant Bio-Rad

K number K024225

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DHN 2003-01-15

LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129

Applicant Bio-Rad

K number K024224

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DHN 2003-01-15

LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112

Applicant Bio-Rad

K number K024222

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DHN 2003-01-15

LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118

Applicant Bio-Rad

K number K024221

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DHN 2003-01-15

LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108

Applicant Bio-Rad

K number K024217

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DHN 2003-01-13

LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118

Applicant Bio-Rad

K number K024231

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DHN 2002-11-25

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM

Applicant Hyperion, Inc.

K number K022800

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DHN 2002-06-04

HYPERION VISIQUANT ANA TEST KIT

Applicant Hyperion, Inc.

K number K013213

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DHN 2001-08-20

POLYTITER SYSTEM

Applicant Polymedco, Inc.

K number K012163

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DHN 2000-08-21

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

Applicant The Binding Site, Ltd.

K number K001556

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DHN 1999-04-21

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

Applicant Stellar Bio Systems, Inc.

K number K990915

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DHN 1998-12-18

LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202

Applicant Bio-Rad

K number K984400

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DHN 1998-12-18

LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204

Applicant Bio-Rad

K number K984399

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DHN 1998-12-18

LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201

Applicant Bio-Rad

K number K984398

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DHN 1998-12-18

LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203

Applicant Bio-Rad

K number K984397

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DHN 1998-12-18

HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO

Applicant Immuno Concepts, Inc.

K number K983924

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DHN 1998-02-24

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K972145

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DHN 1997-02-20

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES

Applicant Scimedx Corp.

K number K970198

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DHN 1997-01-03

MICRO21 WITH NDNA

Applicant Triangle Biomedical Sciences, Inc.

K number K964165

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DHN 1996-12-05

HEMAGEN ENA DSDNA KIT (EIA METHOD)

Applicant Hemagen Diagnostics, Inc.

K number K962276

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DHN 1995-06-01

HEP-2000 COLORZYME ANA-RO TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K950979

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DHN 1994-11-21

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K944096

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DHN 1993-05-20

HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM

Applicant Tissue Culture Biotec, Inc.

K number K926114

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DHN 1991-07-30

DIASTAT ANTI-JO-1 KIT

Applicant Shield Diagnostics, Ltd.

K number K912292

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DHN 1990-05-18

HEMAGEN ENA [JO-I] KIT

Applicant Hemagen Diagnostics, Inc.

K number K902139

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DHN 1990-05-02

NOVA LITE(TM) ANA KSL

Applicant Inova Diagnostics, Inc.

K number K901596

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DHN 1990-04-26

NOVA LITE(TM) ANA MK

Applicant Inova Diagnostics, Inc.

K number K901595

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DHN 1990-01-02

ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K897025

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DHN 1989-09-21

ANA ANTISERA CONTROL KIT

Applicant Lipogen, Inc.

K number K894659

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DHN 1988-11-04

ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)

Applicant Immco Diagnostics, Inc.

K number K884400

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DHN 1988-03-25

NOVA LITE(TM) DSDNA

Applicant Inova Diagnostics, Inc.

K number K880742

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DHN 1988-02-10

COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1

Applicant Diagnostic Products Corp.

K number K874873

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DHN 1987-08-17

BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM

Applicant Bion Ent., Ltd.

K number K872845

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DHN 1987-07-21

ANTI-DNP MICROASSAY

Applicant Diamedix Corp.

K number K872560

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DHN 1987-06-09

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

Applicant Cytotech, Inc.

K number K871801

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DHN 1987-04-29

TANGENT SYSTEM(TM) ANA PROFILE TEST KIT

Applicant Vitrotec Laboratories, Inc.

K number K871144

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DHN 1987-04-20

DUAL SUBSTRATE ANA

Applicant Val Tech Diagnostics, Inc.

K number K871395

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DHN 1987-03-17

HISTONES EIA DIAGNOSTIC KIT

Applicant Biohytech International, Inc.

K number K870458

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DHN 1987-03-10

RAT LIVER NUCLEI TEST SYSTEM

Applicant Val Tech Diagnostics, Inc.

K number K870732

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DHN 1986-10-24

ANTI-DNA MICROASSAY

Applicant Diamedix Corp.

K number K863717

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DHN 1986-08-15

CAPPEL DIAGNOSTICS ANA KIT

Applicant Cappel Diagnostics, Inc.

K number K862821

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DHN 1986-02-26

AFT-HEP SYSTEM

Applicant Behring Diagnostics, Inc.

K number K860183

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DHN 1985-12-16

FANA 60

Applicant American Bio-Reagents, Inc.

K number K854314

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DHN 1985-06-21

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY

Applicant Meloy Laboratories, Inc.

K number K852033

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DHN 1985-05-15

ANTINUCLEAR ANTIBODY TEST KIT

Applicant Modern Diagnostics, Inc.

K number K851369

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DHN 1985-03-14

AUTOFLUOR V SYSTEM

Applicant Tech America Diagnostics

K number K842991

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DHN 1985-01-04

MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL

Applicant Meloy Laboratories, Inc.

K number K844678

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DHN 1984-11-01

COLORZYME NDNA TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K843225

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DHN 1984-11-01

AUTOFLOUR III SYSTEM

Applicant Tech America Diagnostics

K number K841984

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DHN 1984-10-05

RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K843347

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DHN 1984-06-22

ADP ANA IFA TEST

Applicant Apple Diagnostic Products

K number K842183

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DHN 1984-06-22

ANA SENSITIVITY/SPECIFICITY CONTROL

Applicant Behring Diagnostics, Inc.

K number K841776

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DHN 1984-04-25

VIRGO REAGENTS INDIRECT FLUORSCENT

Applicant Electro-Nucleonics Laboratories, Inc.

K number K841127

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DHN 1984-04-04

ANA APPLELISA

Applicant Apple Diagnostic Products

K number K834241

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DHN 1983-11-21

AUTOIMMUNE TEST 1/2/3 SYSTEM

Applicant Atlantic Antibodies

K number K833119

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DHN 1983-08-31

IDT ANA STIQ ASSAY

Applicant Intl. Diagnostic Technology

K number K832383

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DHN 1983-07-28

DNA FLOR

Applicant Medastat Scientific Corp.

K number K831408

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DHN 1983-04-27

ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB

Applicant Immuno-Products Industries

K number K831054

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DHN 1983-03-09

AFT SYSTEM III

Applicant Calbiochem-Behring Corp.

K number K830214

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DHN 1982-12-13

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)

Applicant Amico Lab, Inc.

K number K822681

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DHN 1982-12-03

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K

Applicant Amico Lab, Inc.

K number K822682

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DHN 1982-11-05

FLOUROSET IMMUNOFLUORESCENT ANTIBODY

Applicant Immulok, Inc.

K number K823055

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DHN 1982-10-26

SERA FOR ANTINUCLEAR ANTIBODIES

Applicant Centers for Disease Control and Prevention

K number K820945

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DHN 1982-09-21

ANA HEP-2 FLUORO-KIT

Applicant Clinical Sciences, Inc.

K number K822397

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DHN 1982-09-17

ANTINUCLEAR ANTOBODY CELL SUBSTRATE

Applicant Immulok, Inc.

K number K822607

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DHN 1982-02-12

ANA TEST (MOUSE LIVER SUBSTRATE)

Applicant Meloy Laboratories, Inc.

K number K820265

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DHN 1982-01-18

QUANTAFLUOR FLUORESCENT TEST REAGENTS

Applicant Kallestad Laboratories, Inc.

K number K813592

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DHN 1981-09-01

CRITHIDNA ANTI-DNA TEST KIT

Applicant Antibodies, Inc.

K number K812314

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DHN 1981-07-10

HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT

Applicant Scripps-Miles, Inc.

K number K811714

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DHN 1981-05-01

ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT

Applicant Immuno-Products Industries

K number K810985

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DHN 1981-04-23

ANA TEST KIT

Applicant Immuno-Diagnostic Products, Inc.

K number K811022

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DHN 1981-02-25

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST

Applicant Immuno Concepts, Inc.

K number K810301

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DHN 1981-02-09

SCRIPPSERA ANA REFERENCE CONTROL SERA

Applicant Scripps-Miles, Inc.

K number K810081

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DHN 1981-01-29

K/K (ASMA/ANA) UNIVERSAL BIOPAK

Applicant Bioware Products

K number K802299

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DHN 1981-01-26

ANA-IFA TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K803276

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DHN 1981-01-05

TEST KIT FOR DETECTION OF ANTINUCLEAR

Applicant Bartels & Stout, Inc.

K number K802527

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DHN 1980-05-14

ANATON

Applicant Armkel, LLC

K number K801046

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DHN 1979-11-30

LAB-TEK ANA TEST KIT

Applicant Miles Laboratories, Inc.

K number K792184

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DHN 1979-11-13

ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT

Applicant Keith E. Abbott

K number K791928

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DHN 1979-10-30

ANTI NUCLEAR ANTIBODY TEST

Applicant Meda Stat Diagnostics, Inc.

K number K791995

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DHN 1979-09-24

ANTI-NUCLEAR ANTIBODY TEST

Applicant Meloy Laboratories, Inc.

K number K791493

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DHN 1979-04-23

AUTOANTIBODY REAGENTS, AFT SYSTEM II

Applicant Calbiochem-Behring Corp.

K number K790280

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DHN 1979-03-15

ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI

Applicant Meloy Laboratories, Inc.

K number K790252

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DHN 1979-01-17

TEST KIT, IIF-ANA

Applicant Medica Corp.

K number K782048

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DHN 1979-01-03

FIAX TEST KIT

Applicant Idt, A Division of Whittaker M.A. Bioproducts

K number K782041

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DHN 1978-09-07

FLUORESCENT ANTI-NATIVE DNA TEST

Applicant Kallestad Laboratories, Inc.

K number K780899

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DHN 1978-02-13

TEST SYS. FOR NDNA ANTIBODY DETERM.

Applicant Zeus Scientific, Inc.

K number K780178

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DHN 1978-02-07

IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER

Applicant Zeus Scientific, Inc.

K number K780161

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DHN 1978-01-20

FIAX TEST FOR ANTI-RUBELLA ANTIBODY

Applicant Idt, A Division of Whittaker M.A. Bioproducts

K number K772219

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