Data / Medical devices / Brain Trauma Assessment Test
Brain Trauma Assessment Test (QAT): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Brain Trauma Assessment Test (product code QAT, Class 2, 21 CFR 866.5830). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on May 1, 2024, and lists 0 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.
- Product code
- QAT
- Device class
- 2
- Regulation
- 866.5830
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Ireland | 1 |
| Canada | 1 |
| France | 1 |
Makers of Brain Trauma Assessment Test
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Ireland | Sligo, Ireland | Manufacturer | 2 | September 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 2 | March 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Specification developer | 2 | March 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | May 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biocheck, Inc. | Pleasant Hill, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cliniqa Corporation | San Marcos, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 1, 2024. 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.