Data / Medical devices / Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System / United States
FDA-registered makers of Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (product code PCH). 8 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Product code
- PCH
- Country
- United States
Makers of Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BioFire Diagnostics, LLC | Salt Lake City, UT, United States | Manufacturer | 6 | January 16, 2025 | 0 | 8 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | September 21, 2022 | 0 | 1 | 0 | api.fda.gov |
| Applied BioCode, Inc. | Santa Fe Springs, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | January 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Specification developer | 2 | January 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 2 | January 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 2 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Luminex Corporation | Northbrook, IL, United States | Manufacturer | 2 | May 19, 2026 | 0 | 5 | 0 | api.fda.gov |
| Luminex Corporation | Austin, TX, United States | Manufacturer | 1 | March 21, 2013 | 0 | 1 | 0 | api.fda.gov |
| Biogx | Birmingham, AL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.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.