Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

FDA product code DIC · 33 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3040
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-08 – 2025-09-15

DIC 2025-09-15

Sober Self-Test

Applicant Sober Ip, LLC

K number K250609

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DIC 2018-10-31

Immunalysis Ethyl Alcohol Enzyme Assay

Applicant Immunalysis Corporation

K number K181553

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DIC 2013-03-22

ALCO-SCREEN

Applicant Chematics, Inc.

K number K121247

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DIC 2012-09-12

ALCO-SCREEN 02

Applicant Chematics, Inc.

K number K121256

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DIC 2011-11-15

ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL

Applicant Medica Corp.

K number K111005

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DIC 2011-10-04

TECO DIAGNOSTICS SALIVA ALCOHOL TEST

Applicant Teco Diagnostics

K number K111206

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DIC 2010-11-01

RANDOX ETHANOL ASSAY

Applicant Randox Laboratories, Ltd.

K number K092273

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DIC 2010-08-06

MISSION SALIVA ALCOHOL TEST STRIP

Applicant ACON Laboratories, Inc.

K number K093879

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DIC 2007-08-24

ETOH FLEX REAGENT CARTRIDGE (DF22)

Applicant Dade Behring, Inc.

K number K071811

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DIC 2007-06-13

DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022

Applicant Dade Behring, Inc.

K number K070853

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DIC 2006-07-18

DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI

Applicant Dade Behring, Inc.

K number K061792

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DIC 2003-10-03

ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221

Applicant Lin-Zhi International, Inc.

K number K032461

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DIC 2002-11-18

ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

Applicant Bayer Diagnostics Corp.

K number K023184

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DIC 2001-04-26

EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229

Applicant Syva Co., Dade Behring, Inc.

K number K010960

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DIC 2000-06-20

ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

Applicant Diagnostic Chemicals , Ltd.

K number K001286

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DIC 2000-01-18

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17

Applicant Diagnostic Chemicals , Ltd.

K number K993920

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DIC 1998-04-01

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12

Applicant Diagnostic Chemicals , Ltd.

K number K974002

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DIC 1997-09-25

ALCOHOL REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K972725

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DIC 1997-07-22

OPUS ETHANOL

Applicant Behring Diagnostics, Inc.

K number K972011

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DIC 1996-05-24

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03

Applicant Diagnostic Chemicals , Ltd.

K number K955633

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DIC 1994-04-26

PARAMAX ALCOHOL REAGENT

Applicant Baxter Diagnostics, Inc.

K number K934275

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DIC 1993-07-19

STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY

Applicant Solarcare Technologies Corp,Inc.

K number K931516

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DIC 1991-08-12

ROCHE REAGENT FOR ETHANOL

Applicant Roche Diagnostic Systems, Inc.

K number K913125

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DIC 1990-10-12

DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD

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

K number K904302

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DIC 1990-10-12

STATLAB A-350 SALIVA ALCOHOL TEST

Applicant Enzymatics C/O Burditt,Bowles,Radzius & Ruberry

K number K903235

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DIC 1990-08-09

EMIT ETHYL ALCOHOL ASSAY

Applicant Syva Co.

K number K903153

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DIC 1990-04-05

SALIVA ALCOHOL TEST

Applicant Enzymatics C/O Burditt,Bowles,Radzius & Ruberry

K number K894001

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DIC 1989-08-25

AD X(TM) ETHANOL

Applicant Abbott Laboratories

K number K890743

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DIC 1989-01-24

ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS

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

K number K881344

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DIC 1987-06-11

TDXR REA(TM) ETHANOL

Applicant Abbott Laboratories

K number K871645

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DIC 1985-11-05

DEMAND ETHYL ALCOHOL

Applicant Cooper Biomedical, Inc.

K number K854130

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DIC 1984-04-13

TDX ETHANOL

Applicant Abbott Laboratories

K number K840826

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DIC 1977-06-08

ANTI-CONVULSANT DRUG CONTROL

Applicant Lederle Laboratories

K number K770975

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