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 Jan 25, 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999
Roche Diagnostic Systems, Inc.
Toxicology · 187d
Cleared Dec 09, 1994
ABUSCREEN ONLINE CONTROLS
K945194
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Nov 02, 1994
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL
K943422
Utak Lab, Inc.
Toxicology · 110d
Cleared Oct 06, 1994
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551
Medi-Tech, Inc.
Toxicology · 128d
Cleared Sep 14, 1994
NIDA-5/RT, DRUG OF ABUSE CONTROLS
K942041
Meditech
Toxicology · 139d
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 Apr 21, 1993
PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
K931105
Dynagen, Inc.
Toxicology · 49d
Cleared Feb 25, 1993
COBAS-FP TDM CONTROLS
K930269
Roche Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Dec 28, 1992
DETECTABUSE(TM)
K925586
Biochemical Diagnostic, Inc.
Toxicology · 54d
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