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
97–120 of 202
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
Cleared Apr 01, 1987
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586
Medical Analysis Systems, Inc.
Toxicology · 49d
Cleared Sep 29, 1986
QUANTIMETRIX DRUG FREE SERUM CONTROL
K863388
Quantimetrix Corp.
Toxicology · 26d
Cleared Aug 19, 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970
Bio-Rad
Toxicology · 90d
Cleared Apr 11, 1986
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS
K860919
Fisher Scientific Co., LLC
Toxicology · 31d
Cleared Feb 11, 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933
Quantimetrix Corp.
Chemistry · 10d
Cleared Jul 24, 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414
Bio-Rad
Toxicology · 48d
Cleared Jan 18, 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945
Syva Co.
Toxicology · 29d
Cleared Jan 18, 1985
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
K844946
Syva Co.
Toxicology · 29d
Cleared Oct 30, 1984
HUMAN SERUM ANTICONVULSANT DRUG CONTROL
K843818
Quantimetrix Corp.
Toxicology · 32d
Cleared Oct 30, 1984
COBAS FP TDM CONTROLS
K843913
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Oct 05, 1984
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679
Quantimetrix Corp.
Chemistry · 17d
Cleared Sep 28, 1984
EMIT 700 CONTROL SET B
K843508
Syva Co.
Toxicology · 22d
Cleared Aug 29, 1984
EMIT 700 CONTROL SET A
K843161
Syva Co.
Toxicology · 19d