FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)
Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..
493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
Cleared
Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
Siemens Healthcare Diagnostics, Inc.
Immunology
75d
Cleared
Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
Randox Laboratories, Ltd.
Chemistry
28d
Cleared
Jul 18, 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
Randox Laboratories, Ltd.
Chemistry
31d
Cleared
Jun 14, 2013
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
Maine Standards Co.
Immunology
253d
Cleared
May 31, 2013
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
Bionostics, Inc.
Chemistry
39d
Cleared
Apr 26, 2013
AUDIT MICROCV VITAMIN D LINEARITY SET
Aalto Scientific, Ltd.
Chemistry
37d
Cleared
Mar 19, 2013
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
Aalto Scientific, Ltd.
Chemistry
55d
Cleared
Mar 14, 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
Siemens Healthcare Diagnostics, Inc.
Immunology
206d
Cleared
Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
Bionostics, Inc.
Chemistry
62d
Cleared
Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
Bionostics, Inc.
Chemistry
30d
Cleared
Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
Fujirebio Diagnostics,Inc.
Chemistry
55d
Cleared
Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
Bio-Rad Laboratories
Chemistry
30d
Cleared
Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
Roche Diagnostics
Immunology
131d
Cleared
Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
Roche Diagnostics
Microbiology
56d
Cleared
Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
Immunodiagnostic Systems , Ltd.
Chemistry
19d
Cleared
Jul 11, 2012
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
Randox Laboratories, Ltd.
Chemistry
27d
Cleared
Jun 20, 2012
CONE-TROL HEMOGLOBIN A1C CONTROL SET
Cone Bioproducts
Chemistry
27d
Cleared
Jun 20, 2012
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
Randox Laboratories, Ltd.
Chemistry
20d
Cleared
May 18, 2012
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
Cliniqa Corporation
Chemistry
24d
Cleared
May 10, 2012
COMPLETE D 25-OH VITAMIN D CONTROL
Quantimetrix Corp.
Chemistry
195d
Cleared
May 10, 2012
ELECSYS LH CALCHECK 5
Roche Diagnostics
Chemistry
10d
Cleared
May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
Siemens Healthcare Diagnostics, Inc.
Chemistry
29d
Cleared
Apr 09, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
ACON Laboratories, Inc.
Chemistry
210d
Cleared
Feb 14, 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
Immunodiagnostic Systems , Ltd.
Chemistry
221d