Identity
- Trade Name
- BioTeke FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Model / Reference
- BTK-H2205 FDA UDI
Identifiers
- Catalog Number
- BTK-H2205 FDA UDI
- Primary DI / UDI-DI
- 06974541564403 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
BioTeke by Bioteke Corporation (Wuxi) Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Bioteke Corporation (Wuxi) Co., Ltd.
Sources (1)
- FDA UDI 524e279c-77bf-4d56-ad57-a94ec1d16550 33 fields · synced Jun 8, 2026