Data / Medical devices / Taiwan / Panion & BF Biotech Inc. Xizhi Second Factory
Panion & BF Biotech Inc. Xizhi Second Factory: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Panion & BF Biotech Inc. Xizhi Second Factory is registered with the FDA (registration 3013296716) in New Taipei City, Taiwan. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 14, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013296716
- Address
- 8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City, Taiwan, 221
- Owner or operator
- Panion & BF Biotech Inc (10060384)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- May 6, 2019
- Registered through
- 2026
- Brand names listed
- QwikID, Vstrip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Antigens, Cf (Including Cf Control), Poliovirus 1-3 | GOH | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 14, 2019 | K183573 | Vstrip H. pylori Antigen Rapid Test | LYR | Substantially Equivalent | Panion & BF Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Antigens, All Groups, Streptococcus Spp.
- All makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- All makers of Helicobacter Pylori
- All makers of Antigens, Cf (Including Cf Control), Adenovirus 1-33
Updated March 14, 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.