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Data / Medical devices / Test, Barbiturate, Employment And Insurance Testing, Exempt

Test, Barbiturate, Employment And Insurance Testing, Exempt (PUY): 23 FDA-registered makers in 2 countries

23 establishments in 2 countries are registered with the FDA to make Test, Barbiturate, Employment And Insurance Testing, Exempt (product code PUY, Class 2, 21 CFR 862.3150). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
PUY
Device class
2
Regulation
862.3150
Medical specialty
Clinical Toxicology

Makers by country

CountryMakers
China15
United States8

Makers of Test, Barbiturate, Employment And Insurance Testing, Exempt

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
Advin Biotech, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ameditech, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Eterbio, Inc.Zhuhai Guangdong, ChinaManufacturer0000api.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
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Hangzhou Lysun Biotechnology Co.ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Tongzhou Biotechnology Co., LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, 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
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Mlife Diagnostics LLCMarshall, TX, United StatesManufacturer0000api.fda.gov
Premier Biotech, LLCMinneapolis, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.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
Weihai Kangzhou Biotechnology Engineering Co., Ltd.Weihai Shandong, ChinaManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated November 2, 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.