Product code DIF
- Device name
- Drug Mixture Control Materials
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3280
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153474 | 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 | Biochemical Diagnostics, Inc. | 2016-02-23 |
| K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | Biochemical Diagnostics, Inc. | 2013-12-16 |
| K132174 | MULTICHEM WBT | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Biochemical Diagnostic, Inc. | 2012-07-03 |
| K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | Bio-Rad Laboratories | 2012-05-18 |
| K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | Bio-Rad Laboratories, Inc. | 2012-03-27 |
| K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL | Microgenics Corporation | 2011-03-24 |
| K093577 | LIQUICHEK OPIATE CONTROL | Bio-Rad Laboratories | 2010-03-12 |
| K080085 | MAS TOX CONTROL | Thermo Fisher Scientific | 2008-04-30 |
| 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. | 2008-03-25 |
| K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| K063398 | ESA LEADCARE II LEAD CONTROL | Bionostics, Inc. | 2006-12-05 |
| K062191 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 | Dade Behring, Inc. | 2006-08-21 |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Biosite Incorporated | 2006-07-10 |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | Quantimetrix Corp. | 2006-03-21 |
| K052053 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | Bio-Rad | 2005-08-09 |
| K050682 | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) | Bio-Rad Laboratories, Inc. | 2005-04-29 |
| K050037 | TRIAGE TOX DRUG SCREEN CONTROLS | Biosite Incorporated | 2005-03-22 |
| K042865 | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) | Bio-Rad | 2004-11-24 |
| K041666 | DC-ACETA/SAL CONTROLS | Diagnostic Chemicals , Ltd. | 2004-08-17 |
| K041561 | LIQUICHEK WHOLE BLOOD VOLATILES CONTROL | Bio-Rad | 2004-07-06 |
| K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT | Microgenics Corp. | 2004-05-28 |
| K033924 | LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) | Bio-Rad Laboratories, Inc. | 2004-02-03 |
| K033366 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 | Bio-Rad | 2003-12-12 |
| K033404 | LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) | Bio-Rad | 2003-12-12 |
| K032826 | MAS PAR TDM | Medical Analysis Systems, Inc. | 2003-10-09 |
| K022707 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 | Bio-Rad | 2002-08-22 |
| K021384 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 | Bio-Rad | 2002-05-29 |
| K021414 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 | Bio-Rad | 2002-05-29 |
| K021411 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 | Bio-Rad | 2002-05-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00690286000742 | MEDTOX® | MEDTOX DIAGNOSTICS, INC. | 2026-03-31 |
| 00613647025284 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2023-06-20 |
| 00613647025277 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2023-06-20 |
| B800TCAL2V2SMAYO0 | TRICYCLICS LEVEL 2 V2 | UTAK LABORATORIES, INC. | 2023-01-17 |
| B800TRIC1QDCHANTV20 | TRICYCLICS LEVEL 1 | UTAK LABORATORIES, INC. | 2023-01-12 |
| B800TRIC2QDCHANTV20 | TRICYCLICS LEVEL 2 | UTAK LABORATORIES, INC. | 2023-01-12 |
| B800BARBS500UMAYOV20 | BARBITURATES 500 NG/ML | UTAK LABORATORIES, INC. | 2023-01-10 |
| 00810042683532 | DETECTABUSE | BIOCHEMICAL DIAGNOSTICS INC | 2023-01-09 |
| 00810042683525 | DETECTABUSE | BIOCHEMICAL DIAGNOSTICS INC | 2023-01-09 |
| B800BARBS1UUPENN0 | BARBITURATES LEVEL 1 | UTAK LABORATORIES, INC. | 2022-12-20 |
| B800BARBS2UUPENN0 | BARBITURATES LEVEL 2 | UTAK LABORATORIES, INC. | 2022-12-20 |
| 00810042682870 | DETECTABUSE | BIOCHEMICAL DIAGNOSTICS INC | 2020-11-19 |
| B800663170 | Mid Range Tricyclic Antidepressants VI | UTAK LABORATORIES, INC. | 2020-04-15 |
| B800933120 | Lead Level 2 | UTAK LABORATORIES, INC. | 2020-04-15 |
| B800933110 | Lead Level 1 | UTAK LABORATORIES, INC. | 2020-04-15 |
| B800727410 | Mid Range AED II | UTAK LABORATORIES, INC. | 2020-04-15 |
| B800727400 | High Range AED II | UTAK LABORATORIES, INC. | 2020-04-15 |
| B800663160 | High Range Tricyclic Antidepressants VI | UTAK LABORATORIES, INC. | 2020-04-15 |
| B800933130 | Lead Level 3 | UTAK LABORATORIES, INC. | 2020-04-15 |
| 03610520863732 | Lyphochek | BIO-RAD LABORATORIES, INC. | 2017-09-27 |
| 00842768034145 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001734 | Syva® Emit® Calibrator/Control Level 0 (negative) | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001741 | Syva® Emit® Calibrator/Control Level 1 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001758 | Syva® Emit® Calibrator/Control Level 2 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001772 | Syva® Emit® Calibrator/Control Level 4 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768034138 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630997800 | Cfas DAT Qualitative Plus Clinical | Roche Diagnostics GmbH | 2016-09-20 |
| 00817302020816 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020793 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020786 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |