Drug Mixture Control Materials
FDA product code DIF · Class I (low risk) · 21 CFR 862.3280 · Clinical Toxicology
202510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Bio-Rad 31
- Roche Diagnostic Systems, Inc. 14
- Utak Laboratories, Inc. 13
- Medical Analysis Systems, Inc. 13
- Syva Co. 13
- Quantimetrix Corp. 5
- Bio-Rad Laboratories, Inc. 5
- Biosite Incorporated 4
- Fisher Scientific Co., LLC 4
- Analytical Control Systems, Inc. 3
- Microgenics Corp. 3
- Rapid Diagnostic Laboratories, Inc. 3
- E.I. Dupont DE Nemours & Co., Inc. 3
- General Diagnostics 3
- Medical Diagnostic Technologies, Inc. 3
- Casco Standards 3
- Kaulson Laboratories, Inc. 3
- Medi-Tech, Inc. 3
- Baxter Healthcare Corp 3
- Biochemical Diagnostics, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine…DIF · Traditional | Biochemical Diagnostics, Inc. | 02/23/2016SE |
| K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/NzDIF · Traditional | Biochemical Diagnostics, Inc. | 12/16/2013SE |
| K132174 | Multichem WBTDIF · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
| K121122 | Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid ControlDIF · Traditional | Biochemical Diagnostic, Inc. | 07/03/2012SE |
| K121143 | Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)DIF · Traditional | Bio-Rad Laboratories | 05/18/2012SE |
| K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology…DIF · Traditional | Bio-Rad Laboratories, Inc. | 03/27/2012SE |
| K103656 | Thermo Scientific Mas R Doa TotalDIF · Traditional | Microgenics Corporation | 03/24/2011SE |
| K093577 | Liquichek Opiate ControlDIF · Traditional | Bio-Rad Laboratories | 03/12/2010SE |
| K080085 | Mas Tox ControlDIF · Traditional | Thermo Fisher Scientific | 04/30/2008SE |
| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
| K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCDIF · Traditional | Bio-Rad, Diagnostics Grp. | 12/11/2007SE |
| K063398 | Esa Leadcare II Lead ControlDIF · Traditional | Bionostics, Inc. | 12/05/2006SE |
| K062191 | Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and…DIF · Traditional | Dade Behring, Inc. | 08/21/2006SE |
| K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414DIF · Traditional | Biosite Incorporated | 07/10/2006SE |
| K060417 | Modification to Quantimetrix Urine Drugs of Abuse ControlDIF · Special | Quantimetrix Corp. | 03/21/2006SE |
| K052053 | Liquichek Qualitative Urine Toxicology Control, Negative, Positive, MinipakDIF · Traditional | Bio-Rad | 08/09/2005SE |
| K050682 | Liquichek Urine Toxicology Control (Level C1)DIF · Traditional | Bio-Rad Laboratories, Inc. | 04/29/2005SE |
| K050037 | Triage Tox Drug Screen ControlsDIF · Traditional | Biosite Incorporated | 03/22/2005SE |
| K042865 | Liquichek Urine Toxicology Control, (Levels S1S and S2S)DIF · Traditional | Bio-Rad | 11/24/2004SE |
| K041666 | Dc-Aceta/Sal ControlsDIF · Traditional | Diagnostic Chemicals , Ltd. | 08/17/2004SE |
| K041561 | Liquichek Whole Blood Volatiles ControlDIF · Traditional | Bio-Rad | 07/06/2004SE |
| K040758 | MGC Dau Control Sets: Primary, Clinical and SelectDIF · Traditional | Microgenics Corp. | 05/28/2004SE |
| K033924 | Liquichek Urine Toxicology Control (Screen Series)DIF · Traditional | Bio-Rad Laboratories, Inc. | 02/03/2004SE |
| K033404 | Liquichek Urine Toxicology Control (Confirmatory Series)DIF · Traditional | Bio-Rad | 12/12/2003SE |
| K033366 | Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455DIF · Traditional | Bio-Rad | 12/12/2003SE |
| K032826 | Mas Par TDMDIF · Traditional | Medical Analysis Systems, Inc. | 10/09/2003SE |
| K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439DIF · Traditional | Bio-Rad | 08/22/2002SE |
| K021415 | Liquichek Urine Toxicology Control Level C2 Low Opiate & C3 Low Opiate Models 468 & 469DIF · Traditional | Bio-Rad | 05/29/2002SE |
| K021414 | Liquichek Urine Toxicology Control Level S1 Low Opiate & S2 Low Opiate Models 466 & 467DIF · Traditional | Bio-Rad | 05/29/2002SE |
| K021411 | Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462 & 463DIF · Traditional | Bio-Rad | 05/29/2002SE |
| K021384 | Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444DIF · Traditional | Bio-Rad | 05/29/2002SE |
| K013002 | Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002DIF · Traditional | Biosite Incorporated | 10/03/2001SE |
| K012999 | Triage Tox Drug Screen Controls, Catalog #94001DIF · Traditional | Biosite Incorporated | 10/03/2001SE |
| K012907 | Liquispx Liquid Saliva or Unrine Drug of Abuse ControlDIF · Traditional | Clinical Controls | 09/28/2001SE |
| K012741 | Liquichek TDM ControlDIF · Traditional | Bio-Rad | 09/12/2001SE |
| K012319 | Randox Human Asssayed Drug ControlDIF · Traditional | Randox Laboratories, Ltd. | 08/24/2001SE |
| K992395 | Urine Drug Screening ControlDIF · Traditional | Seracare Technology | 08/26/1999SE |
| K990377 | Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup…DIF · Traditional | Roche Diagnostics Corp. | 02/26/1999SE |
| K983709 | Synchron Systems Dat Low and High Urine Controls 1DIF · Traditional | Beckman Coulter, Inc. | 10/28/1998SE |
| K983387 | Ontrak Testcup and Teststik ControlsDIF · Traditional | Roche Diagnostic Systems, Inc. | 10/09/1998SE |
| K983127 | Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels G2 and G3DIF · Traditional | Medical Analysis Systems, Inc. | 09/14/1998SE |
| K982649 | Vitros Chemistry Products TDM Performance Verifiers I, II, and IIIDIF · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/12/1998SE |
| K982217 | Ac/Ad Linearity VerifiersDIF · Traditional | Sc Calibrators & Controls, LLC | 07/02/1998SE |
| K982024 | Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3DIF · Traditional | Medical Analysis Systems, Inc. | 06/29/1998SE |
| K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level…DIF · Traditional | Bio-Rad | 06/10/1998SE |
| K980871 | Lyphochek Whole Blood ControlDIF · Traditional | Bio-Rad | 04/06/1998SE |
| K980331 | Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos)…DIF · Traditional | More Diagnostics | 03/16/1998SE |
| K972819 | Vigil TDM ControlsDIF · Traditional | Beckman Instruments, Inc. | 08/13/1997SE |
| K971060 | Precinorm TDM ControlsDIF · Traditional | Boehringer Mannheim Corp. | 07/07/1997SE |
| K972174 | Lyphochek Remedi ControlDIF · Traditional | Bio-Rad | 06/24/1997SE |
| K971691 | Liquichek Urine Toxicology Control - Level S1, S2, S3DIF · Traditional | Bio-Rad | 05/30/1997SE |
| K971534 | Synchron Syustems Dat Drug Free Urine ControlDIF · Traditional | Beckman | 05/21/1997SE |
| K971058 | Doa-Xse, Liquid Drugs of Abuse Control Levels 2,3, and 4 (Sdoa- 202,303,404)DIF · Traditional | Medical Analysis Systems, Inc. | 04/08/1997SE |
| K970666 | Liquicheck Urine Toxicology Negative ControlDIF · Traditional | Bio-Rad | 03/10/1997SE |
| K964771 | De-Tox Control 1 and De-Tox Control 19DIF · Traditional | Dyna-Tek Industries | 02/04/1997SE |
| K965157 | Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1DIF · Traditional | Boehringer Mannheim Corp. | 01/17/1997SE |
| K964422 | Ontrak Testtcup Collection/Urinalysis PanelDIF · Traditional | Roche Diagnostic Systems, Inc. | 11/25/1996SE |
| K962165 | Cobas-Fp TDM Calibration Verification Test SetDIF · Traditional | Roche Diagnostic Systems, Inc. | 06/26/1996SE |
| K961724 | U-Doa ControlsDIF · Traditional | Medical Diagnostic Technologies, Inc. | 06/03/1996SE |
| K960244 | Document TDM Ultra Assayed ControlDIF · Traditional | Casco Standards | 03/22/1996SE |
| K955153 | Lyphochek Benzo/Tca Control-Set BDIF · Traditional | Bio-Rad | 02/05/1996SE |
| K955155 | Document TDM Ultra Unassayed ControlDIF · Traditional | Casco Standards | 12/20/1995SE |
| K954799 | Ontraj Testcup Collection/Urinalysis PanelDIF · Traditional | Roche Diagnostic Systems, Inc. | 12/13/1995SE |
| K954291 | Opus TDM ControlsDIF · Traditional | Behring Diagnostics, Inc. | 11/20/1995SE |
| K954322 | Tri-Point Liquimmune Liquid Assayed Immunoassay ControlDIF · Traditional | Medical Analysis Systems, Inc. | 10/11/1995SE |
| K953845 | Abuscreen Online Drug Free UrineDIF · Traditional | Roche Diagnostic Systems, Inc. | 09/20/1995SE |
| K953739 | Abuscreen Online ControlsDIF · Traditional | Roche Diagnostic Systems, Inc. | 09/20/1995SE |
| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | Dupont Medical Products | 06/23/1995SE |
| K951817 | Eli Urine ControlsDIF · Traditional | Elsohly Labs, Inc. | 06/19/1995SE |
| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | Medi-Tech, Inc. | 06/01/1995SE |
| K951135 | Multi-Drug Control SetDIF · Traditional | Microgenics Corp. | 04/13/1995SE |
| K950138 | Drugs of Abuse ControlsDIF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/22/1995SE |
| K943999 | Abuscreen Ontrak Positive ControlDIF · Traditional | Roche Diagnostic Systems, Inc. | 01/25/1995SE |
| K945194 | Abuscreen Online ControlsDIF · Traditional | Roche Diagnostic Systems, Inc. | 12/09/1994SE |
| K943422 | Tri-Level Whole Blood Lead Toxicology ControlDIF · Traditional | Utak Lab, Inc. | 11/02/1994SE |
| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | Medi-Tech, Inc. | 10/06/1994SE |
| K942257 | Doa-Plus, Drugs of Abuse ControlsDIF · Traditional | Medical Diagnostic Technologies, Inc. | 09/14/1994SE |
| K942041 | NIDA-5/RT, Drug of Abuse ControlsDIF · Traditional | Meditech | 09/14/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | Medi-Tech, Inc. | 09/09/1994SE |
| K942114 | Roche TDM Calibration Verification Test SetDIF · Traditional | Roche Diagnostic Systems, Inc. | 09/02/1994SE |
| K940433 | Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4DIF · Traditional | Medical Analysis Systems, Inc. | 07/20/1994SE |
| K936166 | Chemtrak Liquid Unassayed Therapeutic Drug ControlsDIF · Traditional | Medical Analysis Systems, Inc. | 07/13/1994SE |
| K934498 | Doa Liquid Drugs of Abuse ControlsDIF · Traditional | Medical Analysis Systems, Inc. | 07/06/1994SE |
| K934650 | Cedia Dau ControlsDIF · Traditional | Medical Analysis Systems, Inc. | 04/26/1994SE |
| K935285 | Drugs of Abuse ControlsDIF · Traditional | Medical Diagnostic Technologies, Inc. | 03/22/1994SE |
| K935230 | Emit Iic Negative Control, Control I and IIDIF · Traditional | Syva Co. | 01/03/1994SE |
| K934062 | Biotrack Therapeutic Drug-Monitoring Qual ControlsDIF · Traditional | Biotrack, Inc. | 12/29/1993SE |
| K932549 | Abuscreen Online Low-Cutoff ControlsDIF · Traditional | Roche Diagnostic Systems, Inc. | 08/26/1993SE |
| K931125 | Abuscreen Online ControlDIF · Traditional | Roche Diagnostic Systems, Inc. | 08/03/1993SE |
| K932643 | Lyphochek(R) Urine Toxicology Screen-Low ControlDIF · Traditional | Bio-Rad | 07/08/1993SE |
| K931105 | Procheck(Tm) Blind Performance SpecimensDIF · Traditional | Dynagen, Inc. | 04/21/1993SE |
| K930269 | Cobas-Fp TDM ControlsDIF · Traditional | Roche Diagnostic Systems, Inc. | 02/25/1993SE |
| K925586 | Detectabuse(Tm)DIF · Traditional | Biochemical Diagnostic, Inc. | 12/28/1992SE |
| K920477 | Drug of Abuse Urine ControlDIF · Traditional | Diagnostic Reagents, Inc. | 03/18/1992SE |
| K914170 | Liquichek Therapeutic Drug Monitoring Control(Tdm)DIF · Traditional | Bio-Rad | 11/22/1991SE |
| K914806 | Abuscreen(R) Ontrak(R) Positive Reference ControlDIF · Traditional | Roche Diagnostic Systems, Inc. | 11/19/1991SE |
| K913309 | TDM I Linearity Test SetDIF · Traditional | Casco Standards | 09/13/1991SE |
| K913650 | Drug Testing Assessment Program Quality ControlDIF · Traditional | Duo Research, Inc. | 09/06/1991SE |
| K911724 | Aca(R) Urine Drugs of Abuse Control, ModificationDIF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/22/1991SE |
| K911168 | Acs Therapeutic Drug Monit Contr, Set I, Level IIIDIF · Traditional | Analytical Control Systems, Inc. | 05/01/1991SE |
| K911167 | Acs Therapeutic Drug Monit Contr, Set I, Level IIDIF · Traditional | Analytical Control Systems, Inc. | 05/01/1991SE |
| K910930 | Acs Therapeutic Drug Monitoring Control Set I LE.1DIF · Traditional | Analytical Control Systems, Inc. | 05/01/1991SE |
| K905457 | Clinical Chemistry Quality Control MaterialDIF · Traditional | Consolidated Technologies, Inc. | 04/16/1991SE |
| K910333 | Challenge (TM) Liq Thera Drug ControlsDIF · Traditional | Medical Analysis Systems, Inc. | 04/12/1991SE |
| K904905 | Doa Liquid Multi-Analyte Drugs of Abuse ControlsDIF · Traditional | Medical Analysis Systems, Inc. | 12/11/1990SE |
| K903909 | Blind Controls for Drugs of Abuse TestingDIF · Traditional | Rapid Diagnostic Laboratories, Inc. | 10/26/1990SE |
| K903189 | Kodatrol Liquid Control Levels I & IIDIF · Traditional | Eastman Kodak Company | 08/22/1990SE |
| K901270 | Lyphochek Urine Toxicology Control - ScreenDIF · Traditional | Bio-Rad | 05/02/1990SE |
| K901271 | Lyphochek Urine Toxicology Control - ConfirmDIF · Traditional | Bio-Rad | 04/11/1990SE |
| K900626 | Alpha Urine SampleDIF · Traditional | Toxi-Lab, Inc. | 03/06/1990SE |
| K892380 | Dade(R) Immunoassay Controls, Levels I, II, IIIDIF · Traditional | Baxter Healthcare Corp | 02/08/1990SE |
| K895816 | Bio-Rad Blind Perfor. Specimen Set for Nida Reg.DIF · Traditional | Bio-Rad | 12/07/1989SE |
| K893682 | Kit- Ciba Corning L-Tdm I, II, IIIDIF · Traditional | Ciba Corning Diagnostics Corp. | 09/28/1989SE |
| K893835 | Dau I, Dau II, Dau III and Dau IV Control UrineDIF · Traditional | Ciba Corning Diagnostics Corp. | 07/25/1989SE |
| K890957 | Hycor Sentry Drugs of Abuse Urine Control:DIF · Traditional | Hycor Biomedical, Inc. | 03/09/1989SE |
| K884178 | Drug Control SetDIF · Traditional | Gelman Sciences, Inc. | 02/17/1989SE |
| K890406 | Detectabuse Drug ControlsDIF · Traditional | Eastern Laboratories, Ltd. | 02/10/1989SE |
| K890030 | New Low Level Drug Mixture ControlDIF · Traditional | Rapid Diagnostic Laboratories, Inc. | 01/23/1989SE |
| K883210 | Emit (R) Hva Negative UrineDIF · Traditional | Syva Co. | 09/19/1988SE |
| K883190 | Dade TDM ControlDIF · Traditional | Baxter Healthcare Corp | 09/09/1988SE |
| K881944 | Emit Hva Control KitDIF · Traditional | Syva Co. | 07/08/1988SE |
| K881991 | Lyphochek Urine Toxicology Control - NegativeDIF · Traditional | Bio-Rad | 06/20/1988SE |
| K881990 | Lyphochek Urine Toxicology Control - LowDIF · Traditional | Bio-Rad | 06/20/1988SE |
| K881989 | Lyphochek Urine Toxicology ControlDIF · Traditional | Bio-Rad | 06/20/1988SE |
| K880145 | Lyphochek Therapeutic Drug Monitoring ControlDIF · Traditional | Bio-Rad | 06/20/1988SE |
| K880152 | Par(Tm) Brand Drug of Abuse ControlsDIF · Traditional | Medical Analysis Systems, Inc. | 05/31/1988SE |
| K880512 | Drug Mixture Control in UrineDIF · Traditional | Eastern Laboratories, Ltd. | 04/05/1988SE |
| K880445 | Lyphochek Urine Toxicology Control - LowDIF · Traditional | Bio-Rad | 04/05/1988SE |
| K880444 | Lyphochek Urine Toxicology Control - NegativeDIF · Traditional | Bio-Rad | 02/25/1988SE |
| K874757 | Stratus(R) Immunoassay Controls Levels I, II, IIIDIF · Traditional | Baxter Healthcare Corp | 02/02/1988SE |
| K873183 | TDXR Multiconstit. Controls for Abused Drug AssaysDIF · Traditional | Abbott Laboratories | 11/23/1987SE |
| K873539 | Aca Urine Drugs of Abuse ControlDIF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/07/1987SE |
| K873037 | Con-Doa (TM) Drugs of Abuse Urine ControlDIF · Traditional | Diagnostic Products Corp. | 10/02/1987SE |
| K873467 | Quantimetrix Urine Drugs of Abuse ControlDIF · Traditional | Quantimetrix Medical Industries | 09/29/1987SE |
| K871694 | Hyperformance Controls (Hp-Controls)DIF · Traditional | Rapid Diagnostic Laboratories, Inc. | 07/07/1987SE |
| K871788 | Liquid TDM ControlsDIF · Traditional | Biological Industries | 06/17/1987SE |
| K870586 | Tdcontrol Liquid Multi-Analyte Therapeutic DrugDIF · Traditional | Medical Analysis Systems, Inc. | 04/01/1987SE |
| K863388 | Quantimetrix Drug Free Serum ControlDIF · Traditional | Quantimetrix Corp. | 09/29/1986SE |
| K862817 | V-Trend QC TDM Control Serum 1,2,3.DIF · Traditional | Texas Immunology, Inc. | 08/19/1986SE |
| K861970 | Lyphochek Urine Toxicology ControlDIF · Traditional | Bio-Rad | 08/19/1986SE |
| K860919 | Therachem, TDC Therapeutic Drug ControlsDIF · Traditional | Fisher Scientific Co., LLC | 04/11/1986SE |
| K860097 | Therapeutic Drug (TDM) CalibratorDIF · Traditional | Instrumentation Laboratory CO | 02/11/1986SE |
| K853933 | Quantimetrix Human Serum Therapeutic Drug ControlDIF · Traditional | Quantimetrix Corp. | 10/04/1985SE |
| K852414 | Lyphochek Drug Free Serum(Human)DIF · Traditional | Bio-Rad | 07/24/1985SE |
| K844946 | Emit Amitriptyline/Nortriptyline ControlDIF · Traditional | Syva Co. | 01/18/1985SE |
| K844945 | Emit Imipramine/Desipramine ControlDIF · Traditional | Syva Co. | 01/18/1985SE |
| K843913 | Cobas FP TDM ControlsDIF · Traditional | Roche Diagnostic Systems, Inc. | 10/30/1984SE |
| K843818 | Human Serum Anticonvulsant Drug ControlDIF · Traditional | Quantimetrix Corp. | 10/30/1984SE |
| K843679 | Human Serum Cardioactive Drug ControlDIF · Traditional | Quantimetrix Corp. | 10/05/1984SE |
| K843508 | Emit 700 Control Set BDIF · Traditional | Syva Co. | 09/28/1984SE |
| K843161 | Emit 700 Control Set aDIF · Traditional | Syva Co. | 08/29/1984SE |
| K841439 | Coma Toxicology ControlDIF · Traditional | American Dade | 05/16/1984SE |
| K840921 | Therachem TDC Therapeutic Drug ControlDIF · Traditional | Fisher Diagnostics | 04/05/1984SE |
| K834259 | Liqui-Ura Toxic Urine ControlDIF · Traditional | Biodiagnostic Intl | 01/30/1984SE |
| K833794 | Lyphochek Therapeutic Drug ControlDIF · Traditional | Bio-Rad | 01/24/1984SE |
| K831736 | Tricyclic AntidepressantsDIF · Traditional | Utak Laboratories, Inc. | 07/28/1983SE |
| K831741 | Flurazepam Toxicology ControlDIF · Traditional | Utak Laboratories, Inc. | 07/26/1983SE |
| K831734 | Amoxapine 8-HYDRO-XYAMOXAPINEDIF · Traditional | Utak Laboratories, Inc. | 07/26/1983SE |
| K831737 | Tricyclic Antidepressnats ViDIF · Traditional | Utak Laboratories, Inc. | 07/19/1983SE |
| K831740 | Disopyramide N-DesalkyldisopyramideDIF · Traditional | Utak Laboratories, Inc. | 07/06/1983SE |
| K831500 | Tri-Level TDM Control & I II IIIDIF · Traditional | Ortho Diagnostic Systems, Inc. | 06/30/1983SE |
| K831278 | Liqui-Sera Anticonvulsants ControlsDIF · Traditional | Biodiagnostic Intl | 05/27/1983SE |
| K830518 | Emit-St Photometer & Diluter VerificaDIF · Traditional | Syva Co. | 04/05/1983SE |
| K830494 | Contox Drug Screen ControlDIF · Traditional | Kaulson Laboratories, Inc. | 03/11/1983SE |
| K830492 | Contox Durg ControlDIF · Traditional | Kaulson Laboratories, Inc. | 03/11/1983SE |
| K830234 | Contox Heavymetals ControlDIF · Traditional | Kaulson Laboratories, Inc. | 02/18/1983SE |
| K823746 | Advance Sys. Emit-Aed Antiepileptic DrugDIF · Traditional | Syva Co. | 01/12/1983SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | Icl Scientific | 10/08/1982SE |
| K821975 | Ortho*-Bi-Level Assayed Whole Blood ToxDIF · Traditional | Ortho Diagnostic Systems, Inc. | 08/27/1982SE |
| K821973 | Q-Pak Urine Toxicology Control, Unassay.DIF · Traditional | Travenol Laboratories, S.A. | 07/20/1982SE |
| K821950 | Q-Pak Urine Toxicology Control UnassayedDIF · Traditional | Travenol Laboratories, S.A. | 07/20/1982SE |
| K820296 | Stratus TDM Control, Levels I,Ii,IiiDIF · Traditional | American Dade | 05/14/1982SE |
| K820468 | Profile General Set Assayed Serum ContrDIF · Traditional | General Diagnostics | 03/25/1982SE |
| K820462 | Emit-St Urine Controls Set a #3A349DIF · Traditional | Syva Co. | 03/11/1982SE |
| K820191 | Control SetDIF · Traditional | Syva Co. | 02/12/1982SE |
| K813349 | Bi-Level Acetaminophen-Salicylate CNRLDIF · Traditional | Stanbio Laboratory | 12/22/1981SE |
| K812950 | Qac ControlDIF · Traditional | The Quality Assurance Service Corp. | 12/17/1981SE |
| K811756 | Therapeutic Drug ControlDIF · Traditional | Icl Scientific | 07/15/1981SE |
| K811811 | TDM Anti-Convulsant Control Levels I-IiDIF · Traditional | Environmental Chemical Specialties | 07/10/1981SE |
| K811809 | Anti-Arrhythmic Control Levels I & IIDIF · Traditional | Environmental Chemical Specialties | 07/10/1981SE |
| K811618 | Emit-Cad Procainamide/N-Acetyl. ControlDIF · Traditional | Syva Co. | 06/25/1981SE |
| K810504 | Therachem Anti Convulsanta TheophyllineDIF · Traditional | Fisher Scientific Co., LLC | 03/11/1981SE |
| K810468 | Emit-St Serum ControlsDIF · Traditional | Syva Co. | 03/06/1981SE |
| K810235 | Acetaminophen/Salicylate ControlDIF · Traditional | Clin Tech Diagnostics Corp. | 02/10/1981SE |
| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/28/1981SE |
| K803097 | Digoxin & Phenytoin Control SeraDIF · Traditional | Amersham Corp. | 12/22/1980SE |
| K803039 | Profile Anti-Convul. Set Assayed S. Ctl.DIF · Traditional | General Diagnostics | 12/22/1980SE |
| K803036 | Profile Cardiac Set Assayed Serum Contr.DIF · Traditional | General Diagnostics | 12/22/1980SE |
| K802854 | Beckman Ics Drug Control SeraDIF · Traditional | Beckman Instruments, Inc. | 12/11/1980SE |
| K802672 | Cardioactive Drugs ControlDIF · Traditional | Fisher Scientific Co., LLC | 11/24/1980SE |
| K802278 | In Vitro Diagnostic StandardsDIF · Traditional | Supelco, Inc. | 11/24/1980SE |
| K800888 | Tricyclic Antidepressants I TX ControlDIF · Traditional | Utak Laboratories, Inc. | 05/02/1980SE |
| K800889 | Tricyclic Antidepressant II TX ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
| K800887 | Hypnotics Plus Salicylate TX ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
| K800886 | Hypnotics Plus Acetaminophen TX ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
| K800885 | Barbiturates Toxicology ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
| K800884 | Cardiacs II Toxicology ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
| K800883 | Cardiacs I Toxicology ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
| K800882 | Anticonvulsants Toxicology ControlDIF · Traditional | Utak Laboratories, Inc. | 04/29/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0404-2022 Class II | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605Affected product was shipped from the warehouse at room temperature instead of the required refrigerated… | MEDLINE INDUSTRIES, LP - Northfield | 11/30/2021Terminated |
| Z-1552-2020 Class II | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x…Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is… | Quidel Cardiovascular Inc | 04/09/2019Terminated |
| Z-0915-2018 Class II | VITROS Chemistry Products DAT Performance Verifier V in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | Ortho-Clinical Diagnostics | 09/22/2017Terminated |
| Z-0914-2018 Class II | VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | Ortho-Clinical Diagnostics | 09/22/2017Terminated |
| Z-0913-2018 Class II | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | Ortho-Clinical Diagnostics | 09/22/2017Terminated |
| Z-0912-2018 Class II | VITROS Chemistry Products DAT Performance Verifier II in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | Ortho-Clinical Diagnostics | 09/22/2017Terminated |
| Z-0911-2018 Class II | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | Ortho-Clinical Diagnostics | 09/22/2017Terminated |
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