Data / Medical devices / Reagents, Specific, Analyte

Reagents, Specific, Analyte (MVU): 108 FDA-registered makers in 20 countries

108 establishments in 20 countries are registered with the FDA to make Reagents, Specific, Analyte (product code MVU, Class 1, 21 CFR 864.4020). 0 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 35 recall events (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

MVU

Device class

1

Regulation

864.4020

Medical specialty

Pathology

Makers by country

Makers of Reagents, Specific, Analyte

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.