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Data / Medical devices / Acid, Folic, Radioimmunoassay

Acid, Folic, Radioimmunoassay (CGN): 21 FDA-registered makers in 5 countries

21 establishments in 5 countries are registered with the FDA to make Acid, Folic, Radioimmunoassay (product code CGN, Class 2, 21 CFR 862.1295). 11 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 64 510(k) clearances under this code, the latest on June 17, 2024, and lists 20 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
CGN
Device class
2
Regulation
862.1295
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States10
Germany3
Japan3
Ireland3
United Kingdom2

Makers of Acid, Folic, Radioimmunoassay

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler3October 17, 2014000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3April 12, 2018020api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer3April 12, 2018060api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer2August 23, 2023000api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer2October 2, 2009000api.fda.gov
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer1March 5, 2010000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesComplaint file establishment, Manufacturer1May 6, 2020000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1May 2, 2000010api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer1May 2, 2000000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanySpecification developer1June 19, 2009000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer1November 12, 1999000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer0030api.fda.gov
Beckman Coulter Biomedical GmbHMunchen Bavaria, GermanySpecification developer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Ids Co, LtdKumamoto-Shi, JapanContract manufacturer0000api.fda.gov
Kikuyo FactoryKumamoto, JapanManufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov

Updated June 17, 2024. 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.