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 Medical Analysis Systems, Inc..

202
Total
202
Cleared
52d
Avg days
1978
Since
202 devices
73–96 of 202
Cleared Jul 08, 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643
Bio-Rad
Toxicology · 36d
Cleared Feb 25, 1993
COBAS-FP TDM CONTROLS
K930269
Roche Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Mar 18, 1992
DRUG OF ABUSE URINE CONTROL
K920477
Diagnostic Reagents, Inc.
Toxicology · 50d
Cleared Nov 22, 1991
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170
Bio-Rad
Toxicology · 66d
Cleared Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Sep 13, 1991
TDM I LINEARITY TEST SET
K913309
Casco Standards
Chemistry · 50d
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 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 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 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 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
Cleared Jul 08, 1988
EMIT HVA CONTROL KIT
K881944
Syva Co.
Toxicology · 60d
Cleared Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145
Bio-Rad
Toxicology · 159d