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Data / Medical devices / Covid-19 Multi-Analyte Antigen Device

Covid-19 Multi-Analyte Antigen Device (QMN): 25 FDA-registered makers in 3 countries

25 establishments in 3 countries are registered with the FDA to make Covid-19 Multi-Analyte Antigen Device (product code QMN, Class N). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QMN
Device class
N
Medical specialty
Unknown

Makers by country

CountryMakers
United States13
China9
Mexico3

Makers of Covid-19 Multi-Analyte Antigen Device

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
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Acon Biotech (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Andon Medical co., LTDTianjin, ChinaManufacturer0000api.fda.gov
BD Rapid Diagnostics (Suzhou) Co. Ltd.China (Jiangsu) Pilot Free Trade Zone Suzhou Area, ChinaManufacturer0000api.fda.gov
Becton, Dickinson & Co.San Diego, CA, United StatesSpecification developer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Biohit Healthcare (hefei) Co., Ltd.Hefei Anhui, ChinaContract manufacturer0000api.fda.gov
Core Technology Co., Ltd.Changping District Beijing, ChinaContract manufacturer0000api.fda.gov
CorDx, Inc.Alpharetta, GA, United StatesManufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Laboratorios Scantibodies S.A. De C.V.TECATE Baja California, MexicoContract manufacturer0000api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Maq-Ops, S. De R.L.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer for export0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.San Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Carlsbad, CA, United StatesManufacturer0010api.fda.gov
Quidel Corp.San Diego, CA, United StatesManufacturer0000api.fda.gov
Scantibodies Laboratory, Inc.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Wondfo USA Co., Ltd.San Diego, CA, United StatesManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
iHealth Manufacturing IncIrwindale, CA, United StatesContract 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.