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 Utak Laboratories, Inc..

202
Total
202
Cleared
52d
Avg days
1978
Since

FDA 510(k) Cleared Drug Mixture Control Materials Devices (Product Code DIF)

202 devices
1–24 of 202
Cleared Feb 23, 2016
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
K153474
Biochemical Diagnostics, Inc.
Toxicology · 83d
Cleared Dec 16, 2013
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
K132688
Biochemical Diagnostics, Inc.
Toxicology · 110d
Cleared Sep 20, 2013
MULTICHEM WBT
K132174
Techno-Path Manufacturing , Ltd.
Toxicology · 67d
Cleared Jul 03, 2012
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K121122
Biochemical Diagnostic, Inc.
Chemistry · 81d
Cleared May 18, 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143
Bio-Rad Laboratories
Chemistry · 32d
Cleared Mar 27, 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
K120504
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Mar 24, 2011
THERMO SCIENTIFIC MAS R DOA TOTAL
K103656
Microgenics Corporation
Toxicology · 99d
Cleared Mar 12, 2010
LIQUICHEK OPIATE CONTROL
K093577
Bio-Rad Laboratories
Chemistry · 114d
Cleared Apr 30, 2008
MAS TOX CONTROL
K080085
Thermo Fisher Scientific
Toxicology · 110d
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
K080183
Roche Diagnostics Corp.
Chemistry · 60d
Cleared Dec 05, 2006
ESA LEADCARE II LEAD CONTROL
K063398
Bionostics, Inc.
Toxicology · 26d
Cleared Aug 21, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K062191
Dade Behring, Inc.
Toxicology · 21d
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788
Biosite Incorporated
Chemistry · 109d
Cleared Mar 21, 2006
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K060417
Quantimetrix Corp.
Toxicology · 32d
Cleared Aug 09, 2005
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053
Bio-Rad
Toxicology · 11d
Cleared Apr 29, 2005
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682
Bio-Rad Laboratories, Inc.
Toxicology · 44d
Cleared Mar 22, 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037
Biosite Incorporated
Chemistry · 74d
Cleared Nov 24, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865
Bio-Rad
Chemistry · 37d
Cleared Aug 17, 2004
DC-ACETA/SAL CONTROLS
K041666
Diagnostic Chemicals , Ltd.
Toxicology · 60d
Cleared Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561
Bio-Rad
Chemistry · 26d
Cleared May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758
Microgenics Corp.
Toxicology · 64d
Cleared Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924
Bio-Rad Laboratories, Inc.
Chemistry · 47d
Cleared Dec 12, 2003
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366
Bio-Rad
Toxicology · 52d
Cleared Dec 12, 2003
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
K033404
Bio-Rad
Toxicology · 49d

About Product Code DIF - Regulatory Context