Calibrator, Secondary

JIT 2017-04-26

CalSet IGF-1

Applicant Roche Diagnostics

K number K170938

JIT 2017-02-15

Abbott ARCHITECT Free T3

Applicant Abbott Laboratories

K number K170160

JIT 2017-01-13

Lumipulse G Progesterone-N Calibrators

K number K163546

JIT 2017-01-13

Lumipulse G FSH-N Calibrators

K number K163534

JIT 2017-01-12

Lumipulse G Prolactin

K number K163544

JIT 2017-01-12

Lumipulse G LH Calibrators

K number K163521

JIT 2016-12-08

DC-UIBC-CAL

Applicant Sekisui Diagnostics P.E.I., Inc.

K number K163078

JIT 2016-12-01

Lumipulse G E2-III Calibrators

K number K163053

JIT 2016-11-17

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator

K number K162538

JIT 2016-02-17

ST AIA-PACK hsE2 Calibrator Set

Applicant Tosoh Bioscience, Inc.

K number K160113

JIT 2013-12-19

LP(A) CALIBRATORS, AND LP(A) CONTROLS

Applicant Biokit, S.A.

K number K132400

JIT 2013-10-04

PATHFAST CK-MB-II CALIBRATORS

Applicant Mitsubishi Chemical Medience Corporation

K number K130628

JIT 2013-06-26

DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET

Applicant Diazyme Laboratories

K number K131556

JIT 2013-04-05

DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)

K number K130698

JIT 2013-02-15

ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL

Applicant Elitechgroup

K number K122177

JIT 2012-12-20

DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH

K number K121027

JIT 2012-04-17

DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2

K number K120591

JIT 2011-12-30

DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL

K number K113373

JIT 2011-08-19

ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033

Applicant Beckman Coulter, Inc.

K number K111952

JIT 2011-08-05

ST AIA-PACK DHEA-S CALIBRATOR SET

Applicant Tosoh Bioscience, Inc.

K number K111762

JIT 2011-06-10

ABBOTT ARCHITECT LH CALIBRATORS

Applicant Abbott Laboratories

K number K111023

JIT 2011-06-02

ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491

K number K103548

JIT 2011-04-07

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

K number K110169

JIT 2011-02-16

ENZYME II CALIBRATOR

K number K103836

JIT 2010-12-23

ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5

Applicant Roche Diagnostics

K number K103221

JIT 2010-12-17

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

Applicant Siemens Corp.

K number K103360

JIT 2010-11-30

DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS

Applicant Diazyme Laboratories

K number K102638

JIT 2010-08-02

STA-HYBRID HEP CALIBRATOR

Applicant Diagnostica Stago, Inc.

K number K092937

JIT 2010-06-24

DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D

K number K093357

JIT 2010-03-19

ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810

Applicant Siemens Heatlhcare Diagnostics, Inc.

K number K100293

JIT 2009-10-16

ABX PENTRA TPU CAL, MODEL A11A01898

Applicant HORIBA ABX SAS

K number K092570

JIT 2009-02-27

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

K number K083462

JIT 2008-10-10

LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623

K number K082680

JIT 2008-09-10

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

K number K081789

JIT 2008-09-03

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

Applicant Biokit, S.A.

K number K082141

JIT 2008-08-04

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

K number K081319

JIT 2008-07-07

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

K number K081683

JIT 2008-03-19

ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545

Applicant Beckman Coulter, Inc.

K number K080166

JIT 2007-12-12

DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210

Applicant Dade Behring, Inc.

K number K072717

JIT 2007-08-08

MISSION OLYMPUS AU ISE CALIBRATORS

K number K071039

JIT 2007-04-30

DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)

Applicant Dade Behring, Inc.

K number K070552

JIT 2007-03-16

OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

Applicant Thermo-Electron Corp.

K number K062521

JIT 2007-02-01

INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS

Applicant Beckman Coulter, Inc.

K number K070144

JIT 2006-08-24

ABX PENTRA 400: LIPOPROTEINS

Applicant Horiba Abx

K number K060854

JIT 2006-08-16

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

Applicant Dade Behring, Inc.

K number K062152

JIT 2006-08-14

DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250

Applicant Dade Behring, Inc.

K number K061885

JIT 2006-07-18

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

Applicant Dade Behring, Inc.

K number K061818

JIT 2006-07-13

DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260

Applicant Dade Behring, Inc.

K number K061751

JIT 2006-07-10

DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)

Applicant Dade Behring, Inc.

K number K061702

JIT 2006-07-06

BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS

Applicant Bayer Healthcare, LLC

K number K061139

JIT 2006-06-02

ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585

Applicant Beckman Coulter, Inc.

K number K061282

JIT 2006-04-24

CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

Applicant Diagnostic Chemicals , Ltd.

K number K060140

JIT 2006-04-18

ELECSYS TSH CALSET W/MODELS 04738551

Applicant Roche Diagnostics Corp.

K number K060754

JIT 2006-04-14

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10

Applicant Denka Seiken Co., Ltd.

K number K060359

JIT 2006-03-21

CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED

Applicant Cliniqa Corporation

K number K060322

JIT 2006-03-13

FERRITIN CALIBRATOR SET, CATALOG NO. 8203

K number K053291

JIT 2006-03-09

THE EMIT 2000 TACROLIMUS CALIBRATORS

Applicant Dade Behring, Inc.

K number K060371

JIT 2006-02-07

DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR

Applicant Dade Behring, Inc.

K number K053576

JIT 2005-12-16

ARCHITECT B12 CALIBRATORS

Applicant Abbott Laboratories

K number K053330

JIT 2005-11-09

TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET

K number K052148

JIT 2005-10-28

ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

Applicant Roche Diagnostics

K number K052982

JIT 2005-10-03

ISE COMPENSATOR

Applicant Roche Diagnostics

K number K052193

JIT 2005-08-22

IRON STANDARD

Applicant Roche Diagnostics Corp.

K number K052002

JIT 2005-07-19

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

Applicant Salimetrics, LLC

K number K051012

JIT 2005-07-06

ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET

Applicant Roche Diagnostics Corp.

K number K050231

JIT 2004-12-29

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

Applicant Drew Scientific , Ltd.

K number K043378

JIT 2004-12-09

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042838

JIT 2004-12-03

OLYMPUS LACTATE, OSR6193

Applicant Olympus America, Inc.

K number K042406

JIT 2004-11-23

ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

Applicant Roche Diagnostics Corp.

K number K043095

JIT 2004-11-18

VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042521

JIT 2004-11-03

ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)

Applicant Seradyn, Inc.

K number K042307

JIT 2004-10-05

FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

Applicant Beckman Coulter, Inc.

K number K042651

JIT 2004-09-30

ELECSYS FOLATE II CALSET II

Applicant Roche Diagnostics Corp.

K number K042490

JIT 2004-04-23

AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR

Applicant Wako Chemicals USA, Inc.

K number K033860

JIT 2004-04-08

OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023

Applicant Olympus America, Inc.

K number K040692

JIT 2004-03-25

WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET

Applicant Wako Chemicals USA, Inc.

K number K040226

JIT 2004-03-10

OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024

Applicant Olympus America, Inc.

K number K040471

JIT 2004-03-04

CALIBRATING MATERIAL, CALIBRATING STANDARDS

K number K033060

JIT 2004-02-27

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA

Applicant Ibl GmbH

K number K033786

JIT 2004-01-08

CO2 CALIBRATOR/DILUENT

Applicant Bayer Healthcare, Diagnostics Division

K number K033643

JIT 2003-10-06

ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT

Applicant Abbott Laboratories

K number K032458

JIT 2003-08-21

OLYMPUS PREALBUMIN CALIBRATOR, ODR3029

Applicant Olympus America, Inc.

K number K032285

JIT 2003-08-07

VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1

Applicant Ortho-Clinical Diagnostics

K number K031924

JIT 2003-06-25

CALIBRATING MATERIAL, CALIBRATING STANDARDS

K number K031159

JIT 2003-05-12

ELECSYS LH CALSET II

Applicant Roche Diagnostics Corp.

K number K031299

JIT 2003-04-11

RDI EXTENDED RANGE CRP CALIBRATOR SET

K number K030772

JIT 2002-09-30

FASTPACK TESTOSTERONE CALIBRATOR

Applicant Qualigen, Inc.

K number K022533

JIT 2002-07-22

CALIBRATING MATERIAL, BUFFERS, STANDARD

Applicant Mission Diagnostics

K number K022027

JIT 2002-06-27

RDI HS CRP CALIBRATOR SET

K number K021607

JIT 2002-06-27

ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR

Applicant Bayer Diagnostics Corp.

K number K021535

JIT 2002-06-27

ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR

Applicant Bayer Diagnostics Corp.

K number K021532

JIT 2002-06-21

DIMENSION TPSA CALIBRATOR, MODEL #RC459

Applicant Dade Behring, Inc.

K number K020980

JIT 2002-05-08

DIMENSION ALDL CALIBRATOR, MODEL DC131

Applicant Dade Behring, Inc.

K number K020723

JIT 2002-04-29

CALIBRATING MATERIAL, CAL-PAK, BUFFERS

Applicant Mission Diagnostics

K number K020894

JIT 2002-04-08

CHEMISTRY CALIBRATOR

Applicant Jas Diagnostics, Inc.

K number K020454

JIT 2002-03-23

CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS

K number K020596

JIT 2001-12-21

STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE

K number K013850

JIT 2001-10-16

ACCESS UNCONJUGATED ESTRIOL CALIBRATORS

Applicant Beckman Coulter, Inc.

K number K012900

JIT 2001-10-09

VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D

Applicant Nichols Institute Diagnostics

K number K012367