Enzyme Immunoassay, Cocaine And Cocaine Metabolites

FDA product code DIO · 141 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3250
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1984-03-19 – 2022-01-27

DIO 1995-07-14

STC COCAINE METABOLITE EIA

Applicant Solarcare, Inc.

K number K934775

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DIO 1995-03-21

VISUALINE II COCAINE

Applicant Sun Biomedical Laboratories, Inc.

K number K950369

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DIO 1995-02-22

ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC

Applicant Princeton BioMeditech Corp.

K number K945609

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DIO 1995-02-22

EMIT IIC COCAINE METABOLITE ASSAY

Applicant Syva Co.

K number K935323

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DIO 1995-01-17

CEDIA DAU COCAINE ASSAY

Applicant Microgenics Corp.

K number K945345

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DIO 1994-12-02

ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC

Applicant Roche Diagnostic Systems, Inc.

K number K944231

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DIO 1994-11-30

CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS

Applicant Beckman Instruments, Inc.

K number K944087

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DIO 1994-11-17

VERDICT COCAINE

Applicant Editek, Inc.

K number K943710

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DIO 1994-06-02

CEDIA DAU COCAINE ASSAY

Applicant Microgenics Corp.

K number K941310

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DIO 1994-03-11

CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS

Applicant Microgenics Corp.

K number K935904

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DIO 1993-12-03

COCAINE METABOLITE EIA ASSAY MODIFICATION

Applicant Diagnostic Reagents, Inc.

K number K935016

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DIO 1993-08-30

ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF

Applicant Roche Diagnostic Systems, Inc.

K number K933053

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DIO 1993-04-27

USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

Applicant U.S. Drug Testing, Inc.

K number K930985

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DIO 1992-06-15

AUTOMATES COMA COCAINE METABOLITE ASSAY

Applicant Serex, Inc.

K number K921834

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DIO 1991-12-18

COCAINE METABOLITE EIA TEST

Applicant Diagnostic Reagents, Inc.

K number K915371

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DIO 1991-12-10

MICRO EIA FOR COCAINE METABOLITES

Applicant Microdiagnostics, Inc.

K number K914533

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DIO 1991-11-29

SYVA EMIT D.A.U. COCAINE METABOLITE

Applicant Syva Co.

K number K914973

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DIO 1991-05-15

MIRCOLINE SCREEN FOR COCAINE

Applicant Drug Screening Systems, Inc.

K number K911652

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DIO 1990-07-27

EMIT(R) II COCAINE METABOLITE ASSAY

Applicant Syva Co.

K number K902579

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DIO 1990-03-23

MICRO DAU COCAINE METABOLITE TEST KIT

Applicant Immunotech Corp.

K number K896781

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DIO 1990-03-06

HYCOR ACCUPINCH COCAINE TEST

Applicant Hycor Biomedical, Inc.

K number K896937

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DIO 1989-11-08

COMA COCAINE METABOLITE ASSAY (EIA)

Applicant Serex, Inc.

K number K895043

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DIO 1989-08-25

ADX COCAINE METABOLITE

Applicant Abbott Laboratories

K number K890788

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DIO 1989-03-15

ABUSCREEN FP BUFFER REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K890883

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DIO 1989-03-13

ABUSCREEN FP FOR COCAINE METABOLITE

Applicant Roche Diagnostic Systems, Inc.

K number K890885

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DIO 1988-12-16

EZ-SCREEN CANNABINOID/COCAINE

Applicant Environmental Diagnostics, Inc.

K number K883105

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DIO 1988-07-29

ABUSCREEN(R) ONTRAK(TM) FOR COCAINE

Applicant Roche Diagnostic Systems, Inc.

K number K881815

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DIO 1988-07-12

EMIT HVA COCAINE METABOLITE ASSAY

Applicant Syva Co.

K number K881942

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DIO 1988-03-11

REVISED LABELING FOR ADX COCAINE METABOLITE

Applicant Abbott Laboratories

K number K880009

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DIO 1987-11-23

REVISED LABELING FOR TDX COCAINE METABOLITE

Applicant Abbott Laboratories

K number K874487

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DIO 1987-11-13

REVISED LABELING FOR COCAINE/COCAINE META. TEST

Applicant Roche Diagnostic Systems, Inc.

K number K874271

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DIO 1987-11-13

ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN

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

K number K874213

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DIO 1987-10-28

REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY

Applicant Syva Co.

K number K874201

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DIO 1987-10-15

LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY

Applicant Diagnostic Products Corp.

K number K873752

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DIO 1987-10-15

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE

Applicant Diagnostic Products Corp.

K number K873751

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DIO 1987-06-05

COCAINE METABOLITE ENZYME IMMUNOASSAY KIT

Applicant General Diagnostics

K number K871305

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DIO 1987-03-16

COCAINE METABOLITE ROCHE(R) EIA

Applicant Roche Diagnostic Systems, Inc.

K number K863843

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DIO 1985-11-05

TDX COCAINE METABOLITE

Applicant Abbott Laboratories

K number K854163

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DIO 1984-10-05

EMIT D.A.U. COCAINE ASSAY

Applicant Syva Co.

K number K843556

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DIO 1984-08-29

EMIT 700 COCAINE METABOLITE ASSAY

Applicant Syva Co.

K number K843160

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DIO 1984-03-19

EMIT ST. URINE COCAINE METABOLITE

Applicant Syva Co.

K number K834549

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