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
25–48 of 202
Cleared Nov 25, 1996
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
K964422
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Jun 26, 1996
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
K962165
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Feb 05, 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153
Bio-Rad
Toxicology · 84d
Cleared Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799
Roche Diagnostic Systems, Inc.
Toxicology · 56d
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 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 Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114
Roche Diagnostic Systems, Inc.
Chemistry · 122d
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
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 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 May 22, 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 35d
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 19, 1988
EMIT (R) HVA NEGATIVE URINE
K883210
Syva Co.
Toxicology · 52d