Data / Medical devices / Test, Hiv Detection

Test, Hiv Detection (MZF): 28 FDA-registered makers in 10 countries

28 establishments in 10 countries are registered with the FDA to make Test, Hiv Detection (product code MZF, Class 2, 21 CFR 866.3956). 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 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

MZF

Device class

2

Regulation

866.3956

Medical specialty

Microbiology

Makers by country

Makers of Test, Hiv Detection

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.

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.