FDA Registration
Active
🇹🇼 Taiwan
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Reg #: 3013296716
·
FEI: 3013296716
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- Panion & BF Biotech Inc. Xizhi Second Factory
- Registration Number
- 3013296716
- FEI Number
- 3013296716
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist.,
- City
- New Taipei City
- Country
- TW
Owner / Operator
- Firm Name
- Panion & BF Biotech Inc
- Operator Number
- 10060384
- Address
- 8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City, Taiwan
- City
- New Taipei City
- State
- TW-NOTA
- Postal Code
- 221
- Country
- TW
- Correspondent
- Huang Chun-Hao
US Agent
- Business Name
- Arbelos Genomics Inc.
- Contact Name
- Daniel Chen
- Address
- 13768 Roswell Ave. Suite 121, Chino, CA
- City
- Chino
- State
- CA
- ZIP
- 91710
- Country
- US
- [email protected]
- Phone
- 626 4638162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2019-05-27 |
Proprietary Names
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Establishment Types
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device