Skip to the page

Data / Medical devices / Test, Methamphetamine, Over The Counter

Test, Methamphetamine, Over The Counter (NGG): 36 FDA-registered makers in 5 countries

36 establishments in 5 countries are registered with the FDA to make Test, Methamphetamine, Over The Counter (product code NGG, Class 2, 21 CFR 862.3610). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 19, 2018, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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

Makers by country

CountryMakers
China20
United States13
Canada1
Australia1
Indonesia1

Makers of Test, Methamphetamine, Over The Counter

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
Safecare Biotech(hangzhou)co.,ltdHuzhou Zhejiang, ChinaManufacturer1November 19, 2018000api.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 StatesManufacturer0000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anhui Deepblue Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Assure Tech LLCWilmington, DE, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Bioteke Corporation (wuxi) Co., LtdWuxi City Jiangsu, ChinaManufacturer0000api.fda.gov
Boston Easy Biotech IncBelmont, MA, United StatesSpecification developer0000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
Eterbio, Inc.Zhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler0000api.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 Aichek Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Healstone Biotech Inc.Vancouver British Columbia, CanadaComplaint 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
Innovation Scientific Pty LtdVineyard New South Wales, AustraliaContract manufacturer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Mlife Diagnostics LLCMarshall, TX, United StatesContract manufacturer0000api.fda.gov
PT. Jayamas Medica Industri TBKJombang Jawa Timur, IndonesiaContract manufacturer0000api.fda.gov
Qingdao Hightop Biotech Co., Ltd.Qingdao Shandong, ChinaManufacturer0000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaManufacturer0000api.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 November 19, 2018. 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.