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
May 13, 2005
RNA1C CONTROL FOR NYCOCARD HBA1C
Bionostics, Inc.
Chemistry
25d
Cleared
Mar 29, 2005
PREGNANCY-SKREEN
Biochemical Diagnostic, Inc.
Chemistry
48d
Cleared
Feb 25, 2005
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
Bionostics, Inc.
Chemistry
38d
Cleared
Feb 08, 2005
LIQUICHEK BNP CONTROL
Bio-Rad Laboratories, Inc.
Chemistry
42d
Cleared
Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
Roche Diagnostics Corp.
Chemistry
15d
Cleared
Dec 09, 2004
LIQUID STABLE HBA1C CONTROL
Canterbury Scientific , Ltd.
Chemistry
31d
Cleared
Nov 05, 2004
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
Medical Analysis Systems, Inc.
Chemistry
36d
Cleared
Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
Bio-Rad
Chemistry
19d
Cleared
Oct 29, 2004
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
General Atomics
Chemistry
50d
Cleared
Sep 27, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
Ortho-Clinical Diagnostics
Microbiology
33d
Cleared
Aug 19, 2004
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
Home Diagnostics, Inc.
Chemistry
16d
Cleared
Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
Abbott Laboratories
Chemistry
57d
Cleared
Aug 16, 2004
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
Medical Analysis Systems, Inc.
Chemistry
102d
Cleared
Aug 16, 2004
INTERLAB MICROCAL SERUM CONTROLS
Trouble Shooter Consuling, Inc.
Chemistry
38d
Cleared
Aug 16, 2004
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
Cliniqa Corporation
Chemistry
33d
Cleared
May 17, 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
Wako Chemicals USA, Inc.
Chemistry
39d
Cleared
May 17, 2004
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
Cliniqa Corporation
Chemistry
38d
Cleared
May 07, 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
Nova Biomedical Corp.
Chemistry
17d
Cleared
Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
Randox Laboratories, Ltd.
Chemistry
29d
Cleared
Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
R&D Systems, Inc.
Chemistry
71d
Cleared
Mar 05, 2004
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
Cliniqa Corporation
Chemistry
11d
Cleared
Mar 02, 2004
A1C-CELLULAR
Streck Laboratories, Inc.
Chemistry
55d
Cleared
Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
Roche Diagnostics Corp.
Chemistry
33d
Cleared
Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
Nova Biomedical Corp.
Chemistry
66d