Data / Medical devices / Uric Acid Test System For At Home Prescription Use
Uric Acid Test System For At Home Prescription Use (PTC): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Uric Acid Test System For At Home Prescription Use (product code PTC, Class 1, 21 CFR 862.1775). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on April 4, 2025, and lists 1 recall event (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
- PTC
- Device class
- 1
- Regulation
- 862.1775
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Taiwan | 2 |
Makers of Uric Acid Test System For At Home Prescription Use
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 |
|---|---|---|---|---|---|---|---|---|
| Apex Biotechnology Corp. | HSINCHU Hsinchu(County), Taiwan | Exporter to the US, Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | 1 | April 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation Diabetes Products | Billerica, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | 1 | April 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | 1 | April 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Taidoc Technology Corporation | New Taipei City, Taiwan | Manufacturer | 1 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
Updated April 4, 2025. 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.