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
97–120 of 202
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 Feb 17, 1989
DRUG CONTROL SET
K884178
Gelman Sciences, Inc.
Toxicology · 136d
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
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991
Bio-Rad
Toxicology · 39d
Cleared May 31, 1988
PAR(TM) BRAND DRUG OF ABUSE CONTROLS
K880152
Medical Analysis Systems, Inc.
Toxicology · 139d
Cleared Apr 05, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445
Bio-Rad
Toxicology · 63d
Cleared Feb 25, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K880444
Bio-Rad
Toxicology · 23d
Cleared Feb 02, 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757
Baxter Healthcare Corp
Toxicology · 76d
Cleared Nov 23, 1987
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183
Abbott Laboratories
Toxicology · 103d
Cleared Oct 07, 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Oct 02, 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037
Diagnostic Products Corp.
Toxicology · 59d