Gas Chromatography, Methamphetamine

FDA product code LAF · 44 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3610
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1989-01-09 – 2021-12-22

LAF 2021-12-22

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay

Applicant Immunalysis Corporation

K number K203647

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LAF 2021-12-15

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair

Applicant Psychemedics Corporation

K number K210212

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LAF 2020-07-31

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

Applicant Diatron Group

K number K201442

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LAF 2017-08-15

Rapid Tox Cup II

Applicant American Bio Medica Corp.

K number K170222

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LAF 2016-03-18

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Applicant Immunalysis Corporation

K number K153693

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LAF 2012-05-01

PSYCHEMEDICS METHAMPHETAMINE EIA

Applicant Psychemedics Corp.

K number K111927

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LAF 2012-01-23

LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS

Applicant Lin-Zhi International, Inc.

K number K113661

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LAF 2011-09-19

WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K112236

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LAF 2011-08-16

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

Applicant Omega Laboratories, Inc.

K number K101973

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LAF 2011-04-08

THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY

Applicant Microgenics Corp.

K number K101753

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LAF 2011-02-25

ROCHE FLUDI METHAMPHETAMINE

Applicant Roche Diagnostics

K number K093884

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LAF 2008-12-31

RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050

Applicant Quantrx Biomedical Corporation

K number K080455

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LAF 2008-06-25

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA

Applicant Quest Diagnostics, Inc.

K number K080381

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LAF 2006-09-29

METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS

Applicant Lin-Zhi International, Inc.

K number K062242

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LAF 2005-10-04

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS

Applicant Immunalysis Corporation

K number K051577

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LAF 2003-12-12

ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K033299

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LAF 2003-09-15

LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA

Applicant Princeton BioMeditech Corp.

K number K023837

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LAF 2002-12-16

AMEDICA DRUG SCREEN METHAPHETAMINE TEST

Applicant Amedica Biotech, Inc.

K number K023101

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LAF 2002-10-28

ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K022589

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LAF 2002-03-13

AMPHETAMINE/METHAMPHETAMINE

Applicant Abbott Laboratories

K number K012998

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LAF 2001-11-16

AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE

Applicant Ameditech, Inc.

K number K012585

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LAF 2001-07-31

ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K011672

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LAF 2001-06-08

LIVESURE METHAMPHETAMINE SCREEN TESTS

Applicant Pan Probe Biotech, Inc.

K number K011610

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LAF 2001-05-29

CEDIA DAU AMPHETAMINES/ECSTASY ASSAY

Applicant Microgenics Corp.

K number K010496

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LAF 2001-05-29

MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)

Applicant Alfa Scientific Designs, Inc.

K number K003847

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LAF 2001-05-29

MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)

Applicant Alfa Scientific Designs, Inc.

K number K003845

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LAF 2001-04-11

AT WORK DRUG TEST, MODEL 9147T AWT

Applicant Phamatech

K number K010836

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LAF 2001-03-20

ESCREEN SYSTEM

Applicant Escreen, Inc.

K number K003352

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LAF 2000-11-29

FIRST CHECK HOME DRUG TEST PANEL 4

Applicant Worldwide Medical Corp.

K number K993852

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LAF 2000-04-26

ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686

Applicant Roche Diagnostics Corp.

K number K000096

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LAF 2000-04-24

SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

Applicant Drug Detection Devices, Ltd.

K number K000452

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LAF 2000-04-10

REDI-SCREEN

Applicant Redwood Biotech, Inc.

K number K000979

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LAF 2000-04-03

STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I

Applicant OraSure Technologies, Inc.

K number K993208

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LAF 2000-03-07

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225

Applicant Phamatech

K number K000447

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LAF 2000-01-27

SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL

Applicant Syva Co.

K number K993982

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LAF 2000-01-20

IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5

Applicant Diagnostic Products Corp.

K number K992634

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LAF 1999-12-30

AT HOME DRUG TEST, MODEL 9068

Applicant Phamatech

K number K994233

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LAF 1999-07-22

REDI-TEST METHAMPHETAMINE

Applicant Redwood Biotech, Inc.

K number K991504

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LAF 1998-11-18

DBEST METHAMPHETAMINES TEST KIT

Applicant Ameritek, Inc.

K number K983189

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LAF 1997-09-02

QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)

Applicant Phamatech

K number K972556

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LAF 1996-04-25

ACCUSIGN MET/BIOSIGN MET

Applicant Princeton BioMeditech Corp.

K number K961249

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LAF 1991-02-14

TENONE(TM) METHAMPHETAMINE

Applicant Diagnostic Products Corp.

K number K910043

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LAF 1990-11-05

CEDIA(TM) PHENOBARBITAL ASSAY

Applicant Microgenics Corp.

K number K904413

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LAF 1989-01-09

COAT-A-COUNT METHAMPHETAMIN #TKMA1

Applicant Diagnostic Products Corp.

K number K885071

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