Data / Medical devices / Instrumentation For Clinical Multiplex Test Systems

Instrumentation For Clinical Multiplex Test Systems (NSU): 55 FDA-registered makers in 12 countries

55 establishments in 12 countries are registered with the FDA to make Instrumentation For Clinical Multiplex Test Systems (product code NSU, Class 2, 21 CFR 862.2570). 6 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 9, 2017, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

NSU

Device class

2

Regulation

862.2570

Medical specialty

Clinical Chemistry

Makers by country

Makers of Instrumentation For Clinical Multiplex Test Systems

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 June 9, 2017. 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.