Drug Mixture Control Materials

FDA product code DIF · 202 cleared devices

Class 1 Clinical Toxicology

Regulation: 21 CFR 862.3280
Review panel: TX
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-12-07 – 2016-02-23

DIF 1991-05-01

ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II

Applicant Analytical Control Systems, Inc.

K number K911167

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DIF 1991-05-01

ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1

Applicant Analytical Control Systems, Inc.

K number K910930

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DIF 1991-04-16

CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL

Applicant Consolidated Technologies, Inc.

K number K905457

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DIF 1991-04-12

CHALLENGE (TM) LIQ THERA DRUG CONTROLS

Applicant Medical Analysis Systems, Inc.

K number K910333

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DIF 1990-12-11

DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS

Applicant Medical Analysis Systems, Inc.

K number K904905

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DIF 1990-10-26

BLIND CONTROLS FOR DRUGS OF ABUSE TESTING

Applicant Rapid Diagnostic Laboratories, Inc.

K number K903909

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DIF 1990-08-22

KODATROL LIQUID CONTROL LEVELS I & II

Applicant Eastman Kodak Company

K number K903189

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DIF 1990-05-02

LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN

Applicant Bio-Rad

K number K901270

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DIF 1990-04-11

LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM

Applicant Bio-Rad

K number K901271

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DIF 1990-03-06

ALPHA URINE SAMPLE

Applicant Toxi-Lab, Inc.

K number K900626

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DIF 1990-02-08

DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III

Applicant Baxter Healthcare Corp

K number K892380

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DIF 1989-12-07

BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.

Applicant Bio-Rad

K number K895816

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DIF 1989-09-28

KIT- CIBA CORNING L-TDM I, II, III

Applicant Ciba Corning Diagnostics Corp.

K number K893682

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DIF 1989-07-25

DAU I, DAU II, DAU III AND DAU IV CONTROL URINE

Applicant Ciba Corning Diagnostics Corp.

K number K893835

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DIF 1989-03-09

HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:

Applicant Hycor Biomedical, Inc.

K number K890957

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DIF 1989-02-17

DRUG CONTROL SET

Applicant Gelman Sciences, Inc.

K number K884178

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DIF 1989-02-10

DETECTABUSE DRUG CONTROLS

Applicant Eastern Laboratories, Ltd.

K number K890406

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DIF 1989-01-23

NEW LOW LEVEL DRUG MIXTURE CONTROL

Applicant Rapid Diagnostic Laboratories, Inc.

K number K890030

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DIF 1988-09-19

EMIT (R) HVA NEGATIVE URINE

Applicant Syva Co.

K number K883210

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DIF 1988-09-09

DADE TDM CONTROL

Applicant Baxter Healthcare Corp

K number K883190

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DIF 1988-07-08

EMIT HVA CONTROL KIT

Applicant Syva Co.

K number K881944

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DIF 1988-06-20

LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE

Applicant Bio-Rad

K number K881991

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DIF 1988-06-20

LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW

Applicant Bio-Rad

K number K881990

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DIF 1988-06-20

LYPHOCHEK URINE TOXICOLOGY CONTROL

Applicant Bio-Rad

K number K881989

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DIF 1988-06-20

LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL

Applicant Bio-Rad

K number K880145

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DIF 1988-05-31

PAR(TM) BRAND DRUG OF ABUSE CONTROLS

Applicant Medical Analysis Systems, Inc.

K number K880152

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DIF 1988-04-05

DRUG MIXTURE CONTROL IN URINE

Applicant Eastern Laboratories, Ltd.

K number K880512

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DIF 1988-04-05

LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW

Applicant Bio-Rad

K number K880445

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DIF 1988-02-25

LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE

Applicant Bio-Rad

K number K880444

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DIF 1988-02-02

STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III

Applicant Baxter Healthcare Corp

K number K874757

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DIF 1987-11-23

TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS

Applicant Abbott Laboratories

K number K873183

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DIF 1987-10-07

ACA URINE DRUGS OF ABUSE CONTROL

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

K number K873539

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DIF 1987-10-02

CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL

Applicant Diagnostic Products Corp.

K number K873037

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DIF 1987-09-29

QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

Applicant Quantimetrix Medical Industries

K number K873467

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DIF 1987-07-07

HYPERFORMANCE CONTROLS (HP-CONTROLS)

Applicant Rapid Diagnostic Laboratories, Inc.

K number K871694

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DIF 1987-06-17

LIQUID TDM CONTROLS

Applicant Biological Industries

K number K871788

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DIF 1987-04-01

TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG

Applicant Medical Analysis Systems, Inc.

K number K870586

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DIF 1986-09-29

QUANTIMETRIX DRUG FREE SERUM CONTROL

Applicant Quantimetrix Corp.

K number K863388

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DIF 1986-08-19

V-TREND QC TDM CONTROL SERUM 1,2,3.

Applicant Texas Immunology, Inc.

K number K862817

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DIF 1986-08-19

LYPHOCHEK URINE TOXICOLOGY CONTROL

Applicant Bio-Rad

K number K861970

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DIF 1986-04-11

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS

Applicant Fisher Scientific Co., LLC

K number K860919

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DIF 1986-02-11

THERAPEUTIC DRUG (TDM) CALIBRATOR

Applicant Instrumentation Laboratory CO

K number K860097

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DIF 1985-10-04

QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL

Applicant Quantimetrix Corp.

K number K853933

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DIF 1985-07-24

LYPHOCHEK DRUG FREE SERUM(HUMAN)

Applicant Bio-Rad

K number K852414

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DIF 1985-01-18

EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL

Applicant Syva Co.

K number K844946

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DIF 1985-01-18

EMIT IMIPRAMINE/DESIPRAMINE CONTROL

Applicant Syva Co.

K number K844945

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DIF 1984-10-30

COBAS FP TDM CONTROLS

Applicant Roche Diagnostic Systems, Inc.

K number K843913

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DIF 1984-10-30

HUMAN SERUM ANTICONVULSANT DRUG CONTROL

Applicant Quantimetrix Corp.

K number K843818

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DIF 1984-10-05

HUMAN SERUM CARDIOACTIVE DRUG CONTROL

Applicant Quantimetrix Corp.

K number K843679

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DIF 1984-09-28

EMIT 700 CONTROL SET B

Applicant Syva Co.

K number K843508

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DIF 1984-08-29

EMIT 700 CONTROL SET A

Applicant Syva Co.

K number K843161

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DIF 1984-05-16

COMA TOXICOLOGY CONTROL

Applicant American Dade

K number K841439

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DIF 1984-04-05

THERACHEM TDC THERAPEUTIC DRUG CONTROL

Applicant Fisher Diagnostics

K number K840921

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DIF 1984-01-30

LIQUI-URA TOXIC URINE CONTROL

Applicant Biodiagnostic Intl

K number K834259

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DIF 1984-01-24

LYPHOCHEK THERAPEUTIC DRUG CONTROL

Applicant Bio-Rad

K number K833794

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DIF 1983-07-28

TRICYCLIC ANTIDEPRESSANTS

Applicant Utak Laboratories, Inc.

K number K831736

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DIF 1983-07-26

FLURAZEPAM TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K831741

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DIF 1983-07-26

AMOXAPINE 8-HYDRO-XYAMOXAPINE

Applicant Utak Laboratories, Inc.

K number K831734

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DIF 1983-07-19

TRICYCLIC ANTIDEPRESSNATS VI

Applicant Utak Laboratories, Inc.

K number K831737

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DIF 1983-07-06

DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE

Applicant Utak Laboratories, Inc.

K number K831740

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DIF 1983-06-30

TRI-LEVEL TDM CONTROL & I II III

Applicant Ortho Diagnostic Systems, Inc.

K number K831500

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DIF 1983-05-27

LIQUI-SERA ANTICONVULSANTS CONTROLS

Applicant Biodiagnostic Intl

K number K831278

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DIF 1983-04-05

EMIT-ST PHOTOMETER & DILUTER VERIFICA

Applicant Syva Co.

K number K830518

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DIF 1983-03-11

CONTOX DRUG SCREEN CONTROL

Applicant Kaulson Laboratories, Inc.

K number K830494

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DIF 1983-03-11

CONTOX DURG CONTROL

Applicant Kaulson Laboratories, Inc.

K number K830492

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DIF 1983-02-18

CONTOX HEAVYMETALS CONTROL

Applicant Kaulson Laboratories, Inc.

K number K830234

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DIF 1983-01-12

ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG

Applicant Syva Co.

K number K823746

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DIF 1982-10-08

THERAPEUTIC DRUG CONTROL

Applicant Icl Scientific

K number K822777

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DIF 1982-08-27

ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX

Applicant Ortho Diagnostic Systems, Inc.

K number K821975

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DIF 1982-07-20

Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.

Applicant Travenol Laboratories, S.A.

K number K821973

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DIF 1982-07-20

Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED

Applicant Travenol Laboratories, S.A.

K number K821950

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DIF 1982-05-14

STRATUS TDM CONTROL, LEVELS I,II,III

Applicant American Dade

K number K820296

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DIF 1982-03-25

PROFILE GENERAL SET ASSAYED SERUM CONTR

Applicant General Diagnostics

K number K820468

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DIF 1982-03-11

EMIT-ST URINE CONTROLS SET A #3A349

Applicant Syva Co.

K number K820462

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DIF 1982-02-12

CONTROL SET

Applicant Syva Co.

K number K820191

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DIF 1981-12-22

BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL

Applicant Stanbio Laboratory

K number K813349

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DIF 1981-12-17

QAC CONTROL

Applicant The Quality Assurance Service Corp.

K number K812950

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DIF 1981-07-15

THERAPEUTIC DRUG CONTROL

Applicant Icl Scientific

K number K811756

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DIF 1981-07-10

TDM ANTI-CONVULSANT CONTROL LEVELS I-II

Applicant Environmental Chemical Specialties

K number K811811

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DIF 1981-07-10

ANTI-ARRHYTHMIC CONTROL LEVELS I & II

Applicant Environmental Chemical Specialties

K number K811809

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DIF 1981-06-25

EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL

Applicant Syva Co.

K number K811618

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DIF 1981-03-11

THERACHEM ANTI CONVULSANTA THEOPHYLLINE

Applicant Fisher Scientific Co., LLC

K number K810504

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DIF 1981-03-06

EMIT-ST SERUM CONTROLS

Applicant Syva Co.

K number K810468

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DIF 1981-02-10

ACETAMINOPHEN/SALICYLATE CONTROL

Applicant Clin Tech Diagnostics Corp.

K number K810235

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DIF 1981-02-02

Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K810078

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DIF 1981-01-28

OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K810077

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DIF 1980-12-22

DIGOXIN & PHENYTOIN CONTROL SERA

Applicant Amersham Corp.

K number K803097

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DIF 1980-12-22

PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.

Applicant General Diagnostics

K number K803039

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DIF 1980-12-22

PROFILE CARDIAC SET ASSAYED SERUM CONTR.

Applicant General Diagnostics

K number K803036

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DIF 1980-12-11

BECKMAN ICS DRUG CONTROL SERA

Applicant Beckman Instruments, Inc.

K number K802854

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DIF 1980-11-24

CARDIOACTIVE DRUGS CONTROL

Applicant Fisher Scientific Co., LLC

K number K802672

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DIF 1980-11-24

IN VITRO DIAGNOSTIC STANDARDS

Applicant Supelco, Inc.

K number K802278

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DIF 1980-05-02

TRICYCLIC ANTIDEPRESSANTS I TX CONTROL

Applicant Utak Laboratories, Inc.

K number K800888

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DIF 1980-04-29

TRICYCLIC ANTIDEPRESSANT II TX CONTROL

Applicant Utak Laboratories, Inc.

K number K800889

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DIF 1980-04-29

HYPNOTICS PLUS SALICYLATE TX CONTROL

Applicant Utak Laboratories, Inc.

K number K800887

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DIF 1980-04-29

HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL

Applicant Utak Laboratories, Inc.

K number K800886

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DIF 1980-04-29

BARBITURATES TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K800885

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DIF 1980-04-29

CARDIACS II TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K800884

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DIF 1980-04-29

CARDIACS I TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K800883

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DIF 1980-04-29

ANTICONVULSANTS TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K800882

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