Data / Medical devices / Real Time Nucleic Acid Amplification System

Real Time Nucleic Acid Amplification System (OOI): 72 FDA-registered makers in 16 countries

72 establishments in 16 countries are registered with the FDA to make Real Time Nucleic Acid Amplification System (product code OOI, Class 2, 21 CFR 862.2570). 9 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on March 20, 2025, and lists 30 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

OOI

Device class

2

Regulation

862.2570

Medical specialty

Clinical Chemistry

Makers by country

Makers of Real Time Nucleic Acid Amplification System

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 March 20, 2025. 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.