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Data / Medical devices / Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (PCH): 15 FDA-registered makers in 6 countries

15 establishments in 6 countries are registered with the FDA to make Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (product code PCH, Class 2, 21 CFR 866.3990). 12 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on May 19, 2026, and lists 17 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
PCH
Device class
2
Regulation
866.3990
Medical specialty
Microbiology

Makers by country

CountryMakers
United States9
Canada2
Australia1
Germany1
Sweden1
Spain1

Makers of Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Luminex Molecular Diagnostics, Inc.TORONTO Ontario, CanadaManufacturer8November 12, 2019010api.fda.gov
BioFire Diagnostics, LLCSalt Lake City, UT, United StatesManufacturer6January 16, 2025080api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer5September 21, 2022010api.fda.gov
GeneOhm Sciences Canada, ULC.Quebec, CanadaManufacturer5September 21, 2022000api.fda.gov
Applied BioCode, Inc.Santa Fe Springs, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3January 10, 2025000api.fda.gov
CepheidSunnyvale, CA, United StatesManufacturer, Specification developer2January 16, 2026000api.fda.gov
CepheidLodi, CA, United StatesManufacturer2January 16, 2026000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer2September 25, 2025000api.fda.gov
Luminex CorporationNorthbrook, IL, United StatesManufacturer2May 19, 2026050api.fda.gov
Genetic Signatures LimitedNewtown New South Wales, AustraliaComplaint file establishment, Manufacturer1May 29, 2024000api.fda.gov
Luminex CorporationAustin, TX, United StatesManufacturer1March 21, 2013010api.fda.gov
Qiagen, GMBHHILDEN North Rhine-Westphalia, GermanyManufacturer1May 31, 2024000api.fda.gov
BiogxBirmingham, AL, United StatesManufacturer for export0000api.fda.gov
Cepheid ABSOLNA Stockholm, SwedenContract manufacturer0000api.fda.gov
STAT-Dx Life, S.L.Barcelona, SpainContract manufacturer0000api.fda.gov

Updated May 19, 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.