Drug Mixture Control Materials

DIF 2013-12-16

SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ

Applicant Biochemical Diagnostics, Inc.

K number K132688

DIF 2013-09-20

MULTICHEM WBT

Applicant Techno-Path Manufacturing , Ltd.

K number K132174

DIF 2012-07-03

DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL

Applicant Biochemical Diagnostic, Inc.

K number K121122

DIF 2012-05-18

LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

Applicant Bio-Rad Laboratories

K number K121143

DIF 2012-03-27

LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

Applicant Bio-Rad Laboratories, Inc.

K number K120504

DIF 2011-03-24

THERMO SCIENTIFIC MAS R DOA TOTAL

Applicant Microgenics Corporation

K number K103656

DIF 2010-03-12

LIQUICHEK OPIATE CONTROL

Applicant Bio-Rad Laboratories

K number K093577

DIF 2008-04-30

MAS TOX CONTROL

Applicant Thermo Fisher Scientific

K number K080085

DIF 2008-03-25

CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500

Applicant Roche Diagnostics Corp.

K number K080183

DIF 2007-12-11

LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC

Applicant Bio-Rad, Diagnostics Grp.

K number K072721

DIF 2006-12-05

ESA LEADCARE II LEAD CONTROL

Applicant Bionostics, Inc.

K number K063398

DIF 2006-08-21

DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

Applicant Dade Behring, Inc.

K number K062191

DIF 2006-07-10

TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

Applicant Biosite Incorporated

K number K060788

DIF 2006-03-21

MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

Applicant Quantimetrix Corp.

K number K060417

DIF 2005-08-09

LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK

Applicant Bio-Rad

K number K052053

DIF 2005-04-29

LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

Applicant Bio-Rad Laboratories, Inc.

K number K050682

DIF 2005-03-22

TRIAGE TOX DRUG SCREEN CONTROLS

Applicant Biosite Incorporated

K number K050037

DIF 2004-11-24

LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)

Applicant Bio-Rad

K number K042865

DIF 2004-08-17

DC-ACETA/SAL CONTROLS

Applicant Diagnostic Chemicals , Ltd.

K number K041666

DIF 2004-07-06

LIQUICHEK WHOLE BLOOD VOLATILES CONTROL

Applicant Bio-Rad

K number K041561

DIF 2004-05-28

MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT

Applicant Microgenics Corp.

K number K040758

DIF 2004-02-03

LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)

Applicant Bio-Rad Laboratories, Inc.

K number K033924

DIF 2003-12-12

LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)

Applicant Bio-Rad

K number K033404

DIF 2003-12-12

LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455

Applicant Bio-Rad

K number K033366

DIF 2003-10-09

MAS PAR TDM

K number K032826

DIF 2002-08-22

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439

Applicant Bio-Rad

K number K022707

DIF 2002-05-29

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469

Applicant Bio-Rad

K number K021415

DIF 2002-05-29

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467

Applicant Bio-Rad

K number K021414

DIF 2002-05-29

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463

Applicant Bio-Rad

K number K021411

DIF 2002-05-29

LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444

Applicant Bio-Rad

K number K021384

DIF 2001-10-03

TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002

Applicant Biosite Incorporated

K number K013002

DIF 2001-10-03

TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001

Applicant Biosite Incorporated

K number K012999

DIF 2001-09-28

LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL

Applicant Clinical Controls

K number K012907

DIF 2001-09-12

LIQUICHEK TDM CONTROL

Applicant Bio-Rad

K number K012741

DIF 2001-08-24

RANDOX HUMAN ASSSAYED DRUG CONTROL

Applicant Randox Laboratories, Ltd.

K number K012319

DIF 1999-08-26

URINE DRUG SCREENING CONTROL

Applicant Seracare Technology

K number K992395

DIF 1999-02-26

ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV

Applicant Roche Diagnostics Corp.

K number K990377

DIF 1998-10-28

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

Applicant Beckman Coulter, Inc.

K number K983709

DIF 1998-10-09

ONTRAK TESTCUP AND TESTSTIK CONTROLS

K number K983387

DIF 1998-09-14

OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3

K number K983127

DIF 1998-08-12

VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III

Applicant Ortho-Clinical Diagnostics, Inc.

K number K982649

DIF 1998-07-02

AC/AD LINEARITY VERIFIERS

Applicant Sc Calibrators & Controls, LLC

K number K982217

DIF 1998-06-29

OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3

K number K982024

DIF 1998-06-10

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON

Applicant Bio-Rad

K number K981590

DIF 1998-04-06

LYPHOCHEK WHOLE BLOOD CONTROL

Applicant Bio-Rad

K number K980871

DIF 1998-03-16

IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S

Applicant More Diagnostics

K number K980331

DIF 1997-08-13

VIGIL TDM CONTROLS

Applicant Beckman Instruments, Inc.

K number K972819

DIF 1997-07-07

PRECINORM TDM CONTROLS

Applicant Boehringer Mannheim Corp.

K number K971060

DIF 1997-06-24

LYPHOCHEK REMEDI CONTROL

Applicant Bio-Rad

K number K972174

DIF 1997-05-30

LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3

Applicant Bio-Rad

K number K971691

DIF 1997-05-21

SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL

Applicant Beckman

K number K971534

DIF 1997-04-08

DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)

K number K971058

DIF 1997-03-10

LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL

Applicant Bio-Rad

K number K970666

DIF 1997-02-04

DE-TOX CONTROL 1 AND DE-TOX CONTROL 19

Applicant Dyna-Tek Industries

K number K964771

DIF 1997-01-17

CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1

Applicant Boehringer Mannheim Corp.

K number K965157

DIF 1996-11-25

ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL

K number K964422

DIF 1996-06-26

COBAS-FP TDM CALIBRATION VERIFICATION TEST SET

K number K962165

DIF 1996-06-03

U-DOA CONTROLS

Applicant Medical Diagnostic Technologies, Inc.

K number K961724

DIF 1996-03-22

DOCUMENT TDM ULTRA ASSAYED CONTROL

Applicant Casco Standards

K number K960244

DIF 1996-02-05

LYPHOCHEK BENZO/TCA CONTROL-SET B

Applicant Bio-Rad

K number K955153

DIF 1995-12-20

DOCUMENT TDM ULTRA UNASSAYED CONTROL

Applicant Casco Standards

K number K955155

DIF 1995-12-13

ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL

K number K954799

DIF 1995-11-20

OPUS TDM CONTROLS

Applicant Behring Diagnostics, Inc.

K number K954291

DIF 1995-10-11

TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL

K number K954322

DIF 1995-09-20

ABUSCREEN ONLINE DRUG FREE URINE

K number K953845

DIF 1995-09-20

ABUSCREEN ONLINE CONTROLS

K number K953739

DIF 1995-06-23

DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL

Applicant Dupont Medical Products

K number K952412

DIF 1995-06-19

ELI URINE CONTROLS

Applicant Elsohly Labs, Inc.

K number K951817

DIF 1995-06-01

IMMUNOASSAY DRUGS OF ABUSE CONTROLS

Applicant Medi-Tech, Inc.

K number K952056

DIF 1995-04-13

MULTI-DRUG CONTROL SET

Applicant Microgenics Corp.

K number K951135

DIF 1995-02-22

DRUGS OF ABUSE CONTROLS

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K950138

DIF 1995-01-25

ABUSCREEN ONTRAK POSITIVE CONTROL

K number K943999

DIF 1994-12-09

ABUSCREEN ONLINE CONTROLS

K number K945194

DIF 1994-11-02

TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL

Applicant Utak Lab, Inc.

K number K943422

DIF 1994-10-06

THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED

Applicant Medi-Tech, Inc.

K number K942551

DIF 1994-09-14

DOA-PLUS, DRUGS OF ABUSE CONTROLS

Applicant Medical Diagnostic Technologies, Inc.

K number K942257

DIF 1994-09-14

NIDA-5/RT, DRUG OF ABUSE CONTROLS

Applicant Meditech

K number K942041

DIF 1994-09-09

THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED

Applicant Medi-Tech, Inc.

K number K942552

DIF 1994-09-02

ROCHE TDM CALIBRATION VERIFICATION TEST SET

K number K942114

DIF 1994-07-20

DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4

K number K940433

DIF 1994-07-13

CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS

K number K936166

DIF 1994-07-06

DOA LIQUID DRUGS OF ABUSE CONTROLS

K number K934498

DIF 1994-04-26

CEDIA DAU CONTROLS

K number K934650

DIF 1994-03-22

DRUGS OF ABUSE CONTROLS

Applicant Medical Diagnostic Technologies, Inc.

K number K935285

DIF 1994-01-03

EMIT IIC NEGATIVE CONTROL, CONTROL I AND II

Applicant Syva Co.

K number K935230

DIF 1993-12-29

BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS

Applicant Biotrack, Inc.

K number K934062

DIF 1993-08-26

ABUSCREEN ONLINE LOW-CUTOFF CONTROLS

K number K932549

DIF 1993-08-03

ABUSCREEN ONLINE CONTROL

K number K931125

DIF 1993-07-08

LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL

Applicant Bio-Rad

K number K932643

DIF 1993-04-21

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS

Applicant Dynagen, Inc.

K number K931105

DIF 1993-02-25

COBAS-FP TDM CONTROLS

K number K930269

DIF 1992-12-28

DETECTABUSE(TM)

Applicant Biochemical Diagnostic, Inc.

K number K925586

DIF 1992-03-18

DRUG OF ABUSE URINE CONTROL

Applicant Diagnostic Reagents, Inc.

K number K920477

DIF 1991-11-22

LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)

Applicant Bio-Rad

K number K914170

DIF 1991-11-19

ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL

K number K914806

DIF 1991-09-13

TDM I LINEARITY TEST SET

Applicant Casco Standards

K number K913309

DIF 1991-09-06

DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL

Applicant Duo Research, Inc.

K number K913650

DIF 1991-05-22

ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K911724

DIF 1991-05-01

ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III

Applicant Analytical Control Systems, Inc.

K number K911168