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
49–72 of 202
Cleared Feb 05, 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153
Bio-Rad
Toxicology · 84d
Cleared Dec 20, 1995
DOCUMENT TDM ULTRA UNASSAYED CONTROL
K955155
Casco Standards
Chemistry · 37d
Cleared Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799
Roche Diagnostic Systems, Inc.
Toxicology · 56d
Cleared Nov 20, 1995
OPUS TDM CONTROLS
K954291
Behring Diagnostics, Inc.
Toxicology · 67d
Cleared Oct 11, 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322
Medical Analysis Systems, Inc.
Toxicology · 26d
Cleared Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
K953739
Roche Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jun 01, 1995
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056
Medi-Tech, Inc.
Toxicology · 30d
Cleared Apr 13, 1995
MULTI-DRUG CONTROL SET
K951135
Microgenics Corp.
Chemistry · 31d
Cleared Feb 22, 1995
DRUGS OF ABUSE CONTROLS
K950138
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
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 Oct 06, 1994
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551
Medi-Tech, Inc.
Toxicology · 128d
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 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