LAF · Class II · 21 CFR 862.3610

FDA Product Code LAF: Gas Chromatography, Methamphetamine

Gas chromatography provides definitive confirmation of methamphetamine in forensic and clinical samples. FDA product code LAF covers gas chromatography systems for methamphetamine quantification.

These analytical instruments separate and quantify methamphetamine and amphetamine by gas chromatographic separation followed by mass spectrometry or other detection, providing definitive confirmation after immunoassay screening.

LAF devices are Class II medical devices, regulated under 21 CFR 862.3610 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Phamatech, Diagnostic Products Corp. and Microgenics Corp..

49
Total
49
Cleared
148d
Avg days
1989
Since
49 devices
25–48 of 49
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496
Microgenics Corp.
Toxicology · 97d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836
Phamatech
Toxicology · 22d
Cleared Nov 29, 2000
FIRST CHECK HOME DRUG TEST PANEL 4
K993852
Worldwide Medical Corp.
Toxicology · 383d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Apr 03, 2000
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
K993208
OraSure Technologies, Inc.
Toxicology · 192d
Cleared Mar 07, 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
K000447
Phamatech
Toxicology · 26d
Cleared Jan 27, 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982
Syva Co.
Toxicology · 64d
Cleared Jan 20, 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634
Diagnostic Products Corp.
Toxicology · 167d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9068
K994233
Phamatech
Toxicology · 14d
Cleared Jul 22, 1999
REDI-TEST METHAMPHETAMINE
K991504
Redwood Biotech, Inc.
Toxicology · 84d
Cleared Nov 18, 1998
DBEST METHAMPHETAMINES TEST KIT
K983189
Ameritek, Inc.
Toxicology · 68d
Cleared Sep 02, 1997
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556
Phamatech
Toxicology · 55d
Cleared Apr 25, 1996
ACCUSIGN MET/BIOSIGN MET
K961249
Princeton BioMeditech Corp.
Toxicology · 24d
Cleared Feb 14, 1991
TENONE(TM) METHAMPHETAMINE
K910043
Diagnostic Products Corp.
Toxicology · 41d
Cleared Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
K904413
Microgenics Corp.
Toxicology · 40d
Cleared Jan 09, 1989
COAT-A-COUNT METHAMPHETAMIN #TKMA1
K885071
Diagnostic Products Corp.
Toxicology · 32d