Skip to the page
Get started – free

Data / Medical devices / Real Time Nucleic Acid Amplification System / United States

FDA-registered makers of Real Time Nucleic Acid Amplification System in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Real Time Nucleic Acid Amplification System (product code OOI). 5 have a 510(k) clearance or PMA approval on file and 7 have a recall event. 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.

Get makers of this device in the United StatesWatch these makers
Device
Real Time Nucleic Acid Amplification System
Product code
OOI
Country
United States

Makers of Real Time Nucleic Acid Amplification System in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Meridian Bioscience, Inc.Cincinnati, OH, United StatesComplaint file establishment, Manufacturer, Specification developer4March 20, 2025020api.fda.gov
Abbott Molecular, Inc.Des Plaines, IL, United StatesManufacturer, Manufacturer for export, Specification developer1May 28, 2010080api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer1May 20, 2014020api.fda.gov
DiaSorin Molecular LLCCypress, CA, United StatesManufacturer, Specification developer1October 29, 2010020api.fda.gov
Luminex CorporationAustin, TX, United StatesComplaint file establishment, Manufacturer, Remanufacturer1April 12, 2016060api.fda.gov
Autonomous Medical Devices IncorporatedSanta Ana, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Abbott Diagnostics Scarborough, Inc.Scarborough, ME, United StatesManufacturer, Specification developer0000api.fda.gov
Abbott Diagnostics Scarborough, Inc.Portland, ME, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Abbott Molecular Distribution CenterItasca, IL, United StatesManufacturer0000api.fda.gov
Applied BioCode, Inc.Santa Fe Springs, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
BioFire Diagnostics, LLCSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
CepheidSunnyvale, CA, United StatesManufacturer, Manufacturer for export, Specification developer0000api.fda.gov
CepheidLodi, CA, United StatesManufacturer0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
ELITechGroup MDX LLC.Bothell, WA, United StatesManufacturer0000api.fda.gov
Enercon TechnologiesGray, ME, United StatesContract manufacturer0000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
InflammatixSunnyvale, CA, United StatesManufacturer0000api.fda.gov
Luminex CorporationNorthbrook, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Athens, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Planet Innovation Products, Inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
Quidel Corp.San Diego, CA, United StatesManufacturer0000api.fda.gov
Roche Molecular Systems, Inc.Branchburg, NJ, United StatesManufacturer, Manufacturer for export0040api.fda.gov
Roche Molecular Systems, Inc.Pleasanton, CA, United StatesSpecification developer0000api.fda.gov
SanminaSan Jose, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Sanmina CorporationCarrollton, TX, United StatesContract manufacturer0000api.fda.gov
Tecan Cdmo Solutions MH, Corp.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
VWR Chemicals, LLCSolon, OH, United StatesContract manufacturer0000api.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.