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Data / Medical devices / Thin Layer Chromatography, Methamphetamine

Thin Layer Chromatography, Methamphetamine (DJC): 42 FDA-registered makers in 5 countries

42 establishments in 5 countries are registered with the FDA to make Thin Layer Chromatography, Methamphetamine (product code DJC, Class 2, 21 CFR 862.3610). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on March 16, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
United States23
China15
United Kingdom2
Jordan1
Ireland1

Makers of Thin Layer 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
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler3November 13, 2002000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer2July 30, 2002000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer2July 30, 2002000api.fda.gov
Premier Biotech, LLCMinneapolis, MN, United StatesComplaint file establishment, Manufacturer for export, Specification developer2September 20, 2018000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer1July 6, 2016000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1July 6, 2016000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer1November 13, 2002000api.fda.gov
Hangzhou Laihe Biotech Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer1March 18, 2025000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer1March 16, 2026000api.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
Advin Biotech, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Atlas MedicalAmman Al 'Asimah, JordanManufacturer0000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer0000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesManufacturer for export, Repackager or relabeler0000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Core Technology Co., Ltd.Changping District Beijing, ChinaContract manufacturer0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
CorDx, Inc.Alpharetta, GA, United StatesManufacturer0000api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.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
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer0000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer0000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer0000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer0000api.fda.gov
Prometheus Bio Inc.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Randox TeorantaDungloe Donegal, IrelandManufacturer0000api.fda.gov
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated March 16, 2026. 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.