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
25–48 of 202
Cleared Oct 09, 2003
MAS PAR TDM
K032826
Medical Analysis Systems, Inc.
Toxicology · 29d
Cleared Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707
Bio-Rad
Chemistry · 8d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
K021384
Bio-Rad
Chemistry · 27d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
K021414
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
K021415
Bio-Rad
Chemistry · 26d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999
Biosite Incorporated
Toxicology · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002
Biosite Incorporated
Toxicology · 27d
Cleared Sep 12, 2001
LIQUICHEK TDM CONTROL
K012741
Bio-Rad
Chemistry · 27d
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319
Randox Laboratories, Ltd.
Chemistry · 32d
Cleared Aug 26, 1999
URINE DRUG SCREENING CONTROL
K992395
Seracare Technology
Toxicology · 38d
Cleared Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
K990377
Roche Diagnostics Corp.
Toxicology · 18d
Cleared Oct 28, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
K983709
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Sep 14, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
K983127
Medical Analysis Systems, Inc.
Toxicology · 6d
Cleared Aug 12, 1998
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
K982649
Ortho-Clinical Diagnostics, Inc.
Chemistry · 13d
Cleared Jul 02, 1998
AC/AD LINEARITY VERIFIERS
K982217
Sc Calibrators & Controls, LLC
Toxicology · 8d
Cleared Jun 29, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024
Medical Analysis Systems, Inc.
Toxicology · 20d
Cleared Jun 10, 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
K981590
Bio-Rad
Toxicology · 37d
Cleared Apr 06, 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871
Bio-Rad
Toxicology · 46d
Cleared Mar 16, 1998
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
K980331
More Diagnostics
Toxicology · 47d
Cleared Aug 13, 1997
VIGIL TDM CONTROLS
K972819
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Jul 07, 1997
PRECINORM TDM CONTROLS
K971060
Boehringer Mannheim Corp.
Chemistry · 105d
Cleared Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
K972174
Bio-Rad
Toxicology · 15d