FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)
Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.
673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
Cleared
Sep 22, 1998
ELECSYS CALCHECK MYOGLOBIN
Boehringer Mannheim Corp.
Chemistry
12d
Cleared
Aug 12, 1998
TUMOR MARKER CONTROL
Diagnostic Products Corp.
Immunology
27d
Cleared
Aug 12, 1998
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
Diagnostic Products Corp.
Immunology
14d
Cleared
Jul 22, 1998
CHEM-CHEX STAT (NEW)
Streck Laboratories, Inc.
Chemistry
23d
Cleared
Jul 09, 1998
VIGIL PROTEIN CONTROL
Beckman Coulter, Inc.
Chemistry
15d
Cleared
May 18, 1998
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
Boehringer Mannheim Corp.
Chemistry
31d
Cleared
May 13, 1998
THIRD GENERATION PSA CONTROL MODULE
Diagnostic Products Corp.
Chemistry
20d
Cleared
May 12, 1998
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
Bio-Rad
Chemistry
13d
Cleared
Mar 04, 1998
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
Medical Analysis Systems, Inc.
Chemistry
22d
Cleared
Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
Casco Standards
Microbiology
198d
Cleared
Feb 12, 1998
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
Bionostics, Inc.
Chemistry
23d
Cleared
Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
Boehringer Mannheim Corp.
Chemistry
29d
Cleared
Jan 08, 1998
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE
Biosite Incorporated
Chemistry
15d
Cleared
Dec 17, 1997
VIGIL LIPID CONTROL
Beckman Instruments, Inc.
Chemistry
22d
Cleared
Dec 08, 1997
ELECSYS CALCHECK FOLATE
Boehringer Mannheim Corp.
Chemistry
17d
Cleared
Oct 29, 1997
IMMUSURE
Quantimetrix Corp.
Chemistry
15d
Cleared
Oct 07, 1997
PRECINORM RF, PRECIPATH RF
Boehringer Mannheim Corp.
Immunology
13d
Cleared
Aug 28, 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
Bionostics, Inc.
Chemistry
24d
Cleared
Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
Boehringer Mannheim Corp.
Immunology
57d
Cleared
Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
Randox Laboratories, Ltd.
Immunology
54d
Cleared
Jun 26, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
Nichols Institute Diagnostics
Chemistry
23d
Cleared
Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
Roche Diagnostic Systems, Inc.
Chemistry
12d
Cleared
Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
Bio-Rad
Chemistry
19d
Cleared
Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
Bio-Rad
Chemistry
14d