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
73–96 of 202
Cleared Sep 14, 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257
Medical Diagnostic Technologies, Inc.
Toxicology · 128d
Cleared Sep 09, 1994
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
K942552
Medi-Tech, Inc.
Toxicology · 101d
Cleared Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114
Roche Diagnostic Systems, Inc.
Chemistry · 122d
Cleared Jul 20, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4
K940433
Medical Analysis Systems, Inc.
Toxicology · 170d
Cleared Jul 13, 1994
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
K936166
Medical Analysis Systems, Inc.
Toxicology · 203d
Cleared Jul 06, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS
K934498
Medical Analysis Systems, Inc.
Chemistry · 294d
Cleared Apr 26, 1994
CEDIA DAU CONTROLS
K934650
Medical Analysis Systems, Inc.
Toxicology · 209d
Cleared Mar 22, 1994
DRUGS OF ABUSE CONTROLS
K935285
Medical Diagnostic Technologies, Inc.
Toxicology · 139d
Cleared Jan 03, 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230
Syva Co.
Toxicology · 63d
Cleared Dec 29, 1993
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
K934062
Biotrack, Inc.
Toxicology · 132d
Cleared Aug 26, 1993
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Aug 03, 1993
ABUSCREEN ONLINE CONTROL
K931125
Roche Diagnostic Systems, Inc.
Toxicology · 152d
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 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