Data / Medical devices / Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (SAN): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (product code SAN, Class 2, 21 CFR 866.1650). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on July 8, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SAN
- Device class
- 2
- Regulation
- 866.1650
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Sweden | 1 |
Makers of Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
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 |
|---|---|---|---|---|---|---|---|---|
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer | 2 | July 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Affinity Biosensors | Santa Barbara, CA, United States | Complaint file establishment, Specification developer | 1 | April 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Q-linea AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 1 | April 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | West Sacramento, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 8, 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.