Data / Medical devices / Gram-Positive Bacteria And Their Resistance Markers
Gram-Positive Bacteria And Their Resistance Markers (PAM): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Gram-Positive Bacteria And Their Resistance Markers (product code PAM, Class 2, 21 CFR 866.3365). 3 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on August 6, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PAM
- Device class
- 2
- Regulation
- 866.3365
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 1 |
| Spain | 1 |
Makers of Gram-Positive Bacteria And Their Resistance Markers
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Luminex Corporation | Northbrook, IL, United States | Manufacturer | 2 | June 6, 2025 | 0 | 5 | 0 | api.fda.gov |
| Genmark Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | December 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Qiagen, GMBH | HILDEN North Rhine-Westphalia, Germany | Specification developer | 1 | August 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biogx | Birmingham, AL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioFire Diagnostics, LLC | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| STAT-Dx Life, S.L. | Barcelona, Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 6, 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.