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
FDA 510(k) Cleared Drug Mixture Control Materials Devices (Product Code DIF)
202 devices
Cleared
Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
Roche Diagnostics Corp.
Chemistry
60d
Cleared
Aug 21, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
Dade Behring, Inc.
Toxicology
21d
Cleared
Aug 09, 2005
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
Bio-Rad
Toxicology
11d
Cleared
Nov 24, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
Bio-Rad
Chemistry
37d
Cleared
Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
Bio-Rad
Chemistry
26d
Cleared
Dec 12, 2003
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
Bio-Rad
Toxicology
52d
Cleared
Dec 12, 2003
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
Bio-Rad
Toxicology
49d
Cleared
Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
Bio-Rad
Chemistry
8d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
Bio-Rad
Chemistry
27d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
Bio-Rad
Chemistry
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
Bio-Rad
Chemistry
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
Bio-Rad
Chemistry
26d
Cleared
Sep 12, 2001
LIQUICHEK TDM CONTROL
Bio-Rad
Chemistry
27d
Cleared
Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
Roche Diagnostics Corp.
Toxicology
18d
Cleared
Oct 28, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
Beckman Coulter, Inc.
Toxicology
7d
Cleared
Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
Roche Diagnostic Systems, Inc.
Chemistry
14d
Cleared
Jun 10, 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
Bio-Rad
Toxicology
37d
Cleared
Apr 06, 1998
LYPHOCHEK WHOLE BLOOD CONTROL
Bio-Rad
Toxicology
46d
Cleared
Aug 13, 1997
VIGIL TDM CONTROLS
Beckman Instruments, Inc.
Toxicology
15d
Cleared
Jul 07, 1997
PRECINORM TDM CONTROLS
Boehringer Mannheim Corp.
Chemistry
105d
Cleared
Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
Bio-Rad
Toxicology
15d
Cleared
May 30, 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
Bio-Rad
Toxicology
23d
Cleared
Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
Bio-Rad
Chemistry
14d
Cleared
Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
Boehringer Mannheim Corp.
Toxicology
25d