DIF · Class I · 21 CFR 862.3280

FDA Product Code DIF: Drug Mixture Control Materials

Leading manufacturers include Bio-Rad, Roche Diagnostic Systems, Inc. and Syva Co..

202
Total
202
Cleared
52d
Avg days
1978
Since
202 devices
97–120 of 202
Cleared Sep 13, 1991
TDM I LINEARITY TEST SET
K913309
Casco Standards
Chemistry · 50d
Cleared Sep 06, 1991
DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL
K913650
Duo Research, Inc.
Chemistry · 21d
Cleared May 22, 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 35d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930
Analytical Control Systems, Inc.
Chemistry · 56d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
K911167
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared Apr 16, 1991
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL
K905457
Consolidated Technologies, Inc.
Chemistry · 132d
Cleared Apr 12, 1991
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
K910333
Medical Analysis Systems, Inc.
Chemistry · 77d
Cleared Dec 11, 1990
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905
Medical Analysis Systems, Inc.
Chemistry · 42d
Cleared Oct 26, 1990
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING
K903909
Rapid Diagnostic Laboratories, Inc.
Toxicology · 65d
Cleared Aug 22, 1990
KODATROL LIQUID CONTROL LEVELS I & II
K903189
Eastman Kodak Company
Chemistry · 34d
Cleared May 02, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270
Bio-Rad
Toxicology · 44d
Cleared Apr 11, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271
Bio-Rad
Toxicology · 23d
Cleared Mar 06, 1990
ALPHA URINE SAMPLE
K900626
Toxi-Lab, Inc.
Chemistry · 26d
Cleared Feb 08, 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380
Baxter Healthcare Corp
Toxicology · 308d
Cleared Dec 07, 1989
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816
Bio-Rad
Toxicology · 69d
Cleared Sep 28, 1989
KIT- CIBA CORNING L-TDM I, II, III
K893682
Ciba Corning Diagnostics Corp.
Chemistry · 135d
Cleared Jul 25, 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Mar 09, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957
Hycor Biomedical, Inc.
Toxicology · 10d
Cleared Feb 17, 1989
DRUG CONTROL SET
K884178
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 10, 1989
DETECTABUSE DRUG CONTROLS
K890406
Eastern Laboratories, Ltd.
Toxicology · 17d
Cleared Jan 23, 1989
NEW LOW LEVEL DRUG MIXTURE CONTROL
K890030
Rapid Diagnostic Laboratories, Inc.
Toxicology · 19d
Cleared Sep 19, 1988
EMIT (R) HVA NEGATIVE URINE
K883210
Syva Co.
Toxicology · 52d
Cleared Sep 09, 1988
DADE TDM CONTROL
K883190
Baxter Healthcare Corp
Pathology · 43d