Panels › Clinical Toxicology › Product code DIF · Class 1
Drug Mixture Control Materials
Regulation 862.3280
0510(k)s in 12 months (202 all time)
0recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in DIF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2016 | K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Biochemical Diagnostics, Inc. | DIF |
| Dec 16, 2013 | K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ Biochemical Diagnostics, Inc. | DIF |
| Sep 20, 2013 | K132174 | MULTICHEM WBT Techno-Path Manufacturing , Ltd. | DIF |
| Jul 3, 2012 | K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL Biochemical Diagnostic, Inc. | DIF |
| May 18, 2012 | K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) Bio-Rad Laboratories | DIF |
| Mar 27, 2012 | K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK Bio-Rad Laboratories, Inc. | DIF |
| Mar 24, 2011 | K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL Microgenics Corporation | DIF |
| Mar 12, 2010 | K093577 | LIQUICHEK OPIATE CONTROL Bio-Rad Laboratories | DIF |
| Apr 30, 2008 | K080085 | MAS TOX CONTROL Thermo Fisher Scientific | DIF |
| Mar 25, 2008 | K080183 | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 Roche Diagnostics Corp. | DIF |
| Dec 11, 2007 | K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC Bio-Rad, Diagnostics Grp. | DIF |
| Dec 5, 2006 | K063398 | ESA LEADCARE II LEAD CONTROL Bionostics, Inc. | DIF |
| Aug 21, 2006 | K062191 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 Dade Behring, Inc. | DIF |
| Jul 10, 2006 | K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 Biosite Incorporated | DIF |
| Mar 21, 2006 | K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL Quantimetrix Corp. | DIF |
| Aug 9, 2005 | K052053 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK Bio-Rad | DIF |
| Apr 29, 2005 | K050682 | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) Bio-Rad Laboratories, Inc. | DIF |
| Mar 22, 2005 | K050037 | TRIAGE TOX DRUG SCREEN CONTROLS Biosite Incorporated | DIF |
| Nov 24, 2004 | K042865 | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) Bio-Rad | DIF |
| Aug 17, 2004 | K041666 | DC-ACETA/SAL CONTROLS Diagnostic Chemicals , Ltd., CA | DIF |
| Jul 6, 2004 | K041561 | LIQUICHEK WHOLE BLOOD VOLATILES CONTROL Bio-Rad | DIF |
| May 28, 2004 | K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT Microgenics Corp. | DIF |
| Feb 3, 2004 | K033924 | LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) Bio-Rad Laboratories, Inc. | DIF |
| Dec 12, 2003 | K033404 | LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) Bio-Rad | DIF |
| Dec 12, 2003 | K033366 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 Bio-Rad | DIF |
| Oct 9, 2003 | K032826 | MAS PAR TDM Medical Analysis Systems, Inc. | DIF |
| Aug 22, 2002 | K022707 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 Bio-Rad | DIF |
| May 29, 2002 | K021415 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 Bio-Rad | DIF |
| May 29, 2002 | K021414 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 Bio-Rad | DIF |
| May 29, 2002 | K021411 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 Bio-Rad | DIF |
| May 29, 2002 | K021384 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 Bio-Rad | DIF |
| Oct 3, 2001 | K013002 | TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 Biosite Incorporated | DIF |
| Oct 3, 2001 | K012999 | TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 Biosite Incorporated | DIF |
| Sep 28, 2001 | K012907 | LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL Clinical Controls | DIF |
| Sep 12, 2001 | K012741 | LIQUICHEK TDM CONTROL Bio-Rad | DIF |
| Aug 24, 2001 | K012319 | RANDOX HUMAN ASSSAYED DRUG CONTROL Randox Laboratories, Ltd., GB | DIF |
| Aug 26, 1999 | K992395 | URINE DRUG SCREENING CONTROL Seracare Technology | DIF |
| Feb 26, 1999 | K990377 | ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV Roche Diagnostics Corp. | DIF |
| Oct 28, 1998 | K983709 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 Beckman Coulter, Inc. | DIF |
| Oct 9, 1998 | K983387 | ONTRAK TESTCUP AND TESTSTIK CONTROLS Roche Diagnostic Systems, Inc. | DIF |
| Sep 14, 1998 | K983127 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 Medical Analysis Systems, Inc. | DIF |
| Aug 12, 1998 | K982649 | VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III Ortho-Clinical Diagnostics, Inc. | DIF |
| Jul 2, 1998 | K982217 | AC/AD LINEARITY VERIFIERS Sc Calibrators & Controls, LLC | DIF |
| Jun 29, 1998 | K982024 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 Medical Analysis Systems, Inc. | DIF |
| Jun 10, 1998 | K981590 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON Bio-Rad | DIF |
| Apr 6, 1998 | K980871 | LYPHOCHEK WHOLE BLOOD CONTROL Bio-Rad | DIF |
| Mar 16, 1998 | K980331 | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S More Diagnostics | DIF |
| Aug 13, 1997 | K972819 | VIGIL TDM CONTROLS Beckman Instruments, Inc. | DIF |
| Jul 7, 1997 | K971060 | PRECINORM TDM CONTROLS Boehringer Mannheim Corp. | DIF |
| Jun 24, 1997 | K972174 | LYPHOCHEK REMEDI CONTROL Bio-Rad | DIF |
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