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, ACON Laboratories, Inc. and Immunalysis Corporation.
49
Total
49
Cleared
148d
Avg days
1989
Since
49 devices
Cleared
Jan 27, 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
Syva Co.
Toxicology
64d
Cleared
Jan 20, 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
Diagnostic Products Corp.
Toxicology
167d
Cleared
Dec 30, 1999
AT HOME DRUG TEST, MODEL 9068
Phamatech
Toxicology
14d
Cleared
Sep 02, 1997
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
Phamatech
Toxicology
55d
Cleared
Apr 25, 1996
ACCUSIGN MET/BIOSIGN MET
Princeton BioMeditech Corp.
Toxicology
24d
Cleared
Feb 14, 1991
TENONE(TM) METHAMPHETAMINE
Diagnostic Products Corp.
Toxicology
41d
Cleared
Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
Microgenics Corp.
Toxicology
40d
Cleared
Jan 09, 1989
COAT-A-COUNT METHAMPHETAMIN #TKMA1
Diagnostic Products Corp.
Toxicology
32d