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
| Country | Makers |
|---|---|
| United States | 24 |
| China | 13 |
| Australia | 1 |
| Germany | 1 |
| United Kingdom | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alere San Diego, Inc. | San Diego, CA, United States | Specification developer | 3 | December 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | May 29, 2001 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Specification developer | 2 | October 28, 2002 | 0 | 0 | 0 | api.fda.gov |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 2 | March 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 2 | April 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer, Manufacturer for export | 1 | March 18, 2016 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | July 31, 2001 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 1 | March 4, 2015 | 0 | 0 | 0 | api.fda.gov |
| Omega Laboratories, Inc. | Mogadore, OH, United States | Manufacturer | 1 | August 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Phamatech Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 1 | September 2, 1997 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | April 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | April 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | April 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | April 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | Manufacturer | 1 | February 26, 2015 | 0 | 0 | 0 | api.fda.gov |
| Abon Biopharm (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ABOUND Diagnostics, Inc | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemtron Biotech, Inc. | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hongkong Conlight Medical Group Limited | Tai Kok Tsui Hong Kong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovation Scientific Pty Ltd | Vineyard New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Disposables Corp | Orlando, FL, United States | Complaint file establishment, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong Egens Biotechnology Co.,ltd. | NANTONG Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Cardiovascular Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ucp Biosciences, Inc. | Milpitas, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M., Inc. | Irwindale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.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.