Data / Medical devices / Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens (QID): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens (product code QID, Class 2, 21 CFR 866.4002). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 10, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QID
- Device class
- 2
- Regulation
- 866.4002
- Medical specialty
- Microbiology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
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 |
|---|---|---|---|---|---|---|---|---|
| Orasure Technologies Inc. | Bethlehem, PA, United States | Manufacturer | 1 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Orasure Technologies, Inc. | Bethlehem, PA, United States | Manufacturer | 1 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Orasure Technologies, Inc. | Bethlehem, PA, United States | Complaint file establishment, Specification developer | 1 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
Updated October 10, 2019. 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.