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Data / Medical devices / Gas Chromatography, Methamphetamine

Gas Chromatography, Methamphetamine (LAF): 40 FDA-registered makers in 5 countries

40 establishments in 5 countries are registered with the FDA to make Gas Chromatography, Methamphetamine (product code LAF, Class 2, 21 CFR 862.3610). 15 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 49 510(k) clearances under this code, the latest on December 22, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
LAF
Device class
2
Regulation
862.3610
Medical specialty
Clinical Toxicology

Makers by country

CountryMakers
United States24
China13
Australia1
Germany1
United Kingdom1

Makers of Gas Chromatography, Methamphetamine

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer3December 12, 2003000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2May 29, 2001000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer2October 28, 2002000api.fda.gov
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer2March 21, 2014000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer2April 8, 2011000api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer, Manufacturer for export1March 18, 2016000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1July 31, 2001000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer1March 4, 2015000api.fda.gov
Omega Laboratories, Inc.Mogadore, OH, United StatesManufacturer1August 16, 2011000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler1September 2, 1997000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer1April 25, 1996000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer1April 25, 1996000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer1April 25, 1996000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer1April 25, 1996000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer1February 26, 2015000api.fda.gov
Abon Biopharm (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Hongkong Conlight Medical Group LimitedTai Kok Tsui Hong Kong, ChinaManufacturer, Specification developer0000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Innovation Scientific Pty LtdVineyard New South Wales, AustraliaContract manufacturer0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Nantong Egens Biotechnology Co.,ltd.NANTONG Jiangsu, ChinaManufacturer0000api.fda.gov
Quidel Cardiovascular Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer0000api.fda.gov
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov

Updated December 22, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.