FDA Product Code JIT: Calibrator, Secondary
Leading manufacturers include Dade Behring, Inc., Wako Chemicals USA, Inc. and Roche Diagnostics Corp..
245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
Cleared
Mar 27, 2014
PATHFAST CTNL CALIBRATORS
Mitsubishi Chemical Medience Corporation
Chemistry
385d
Cleared
Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
Biokit, S.A.
Chemistry
140d
Cleared
Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
Mitsubishi Chemical Medience Corporation
Chemistry
210d
Cleared
Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
Diazyme Laboratories
Chemistry
28d
Cleared
Apr 05, 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
Siemens Healthcare Diagnostics
Chemistry
22d
Cleared
Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
Elitechgroup
Chemistry
207d
Cleared
Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
Diamond Diagnostics, Inc.
Chemistry
260d
Cleared
Apr 17, 2012
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
Diamond Diagnostics, Inc.
Chemistry
49d
Cleared
Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
Siemens Healthcare Diagnostics, Inc.
Chemistry
44d
Cleared
Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
Beckman Coulter, Inc.
Chemistry
39d
Cleared
Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
Tosoh Bioscience, Inc.
Chemistry
43d
Cleared
Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
Abbott Laboratories
Chemistry
58d
Cleared
Jun 02, 2011
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
Siemens Healthcare Diagnostics, Inc.
Immunology
181d
Cleared
Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
Siemens Healthcare Diagnostics
Chemistry
77d
Cleared
Feb 16, 2011
ENZYME II CALIBRATOR
Siemens Healthcare Diagnostics, Inc.
Chemistry
48d
Cleared
Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
Roche Diagnostics
Chemistry
52d
Cleared
Dec 17, 2010
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
Siemens Corp.
Chemistry
31d
Cleared
Nov 30, 2010
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
Diazyme Laboratories
Chemistry
77d
Cleared
Aug 02, 2010
STA-HYBRID HEP CALIBRATOR
Diagnostica Stago, Inc.
Hematology
312d
Cleared
Jun 24, 2010
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
Diamond Diagnostics, Inc.
Chemistry
239d
Cleared
Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
HORIBA ABX SAS
Chemistry
56d
Cleared
Feb 27, 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
Siemens Healthcare Diagnostics
Chemistry
95d
Cleared
Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
Siemens Healthcare Diagnostics
Chemistry
25d
Cleared
Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
Siemens Healthcare Diagnostics, Inc.
Chemistry
77d