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Data / Medical devices / Reagents, Specific, Analyte / Germany

FDA-registered makers of Reagents, Specific, Analyte in Germany: 7 establishments

7 establishments in Germany are registered with the FDA to make Reagents, Specific, Analyte (product code MVU). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Reagents, Specific, Analyte
Product code
MVU
Country
Germany

Makers of Reagents, Specific, Analyte in Germany

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Metasystems Probes GMBHAltlussheim Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Miltenyi Biotec B. V. & Co. KGBergisch Gladbach North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Miltenyi Biotec B. V. & Co. KG Branch TeterowTeterow Mecklenburg-Western Pomerania, GermanyManufacturer0000api.fda.gov
Qiagen, GMBHHILDEN North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Rommelag CDMO GmbHSulzbach-Laufen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Zytovision GMBHBremerhaven Bremen, GermanyManufacturer0000api.fda.gov
altona Diagnostics GmbHHamburg, GermanyManufacturer0000api.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.