Identity
- Trade Name
- BIOER Viral Transport Medium FDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDI
- Device Name
- For the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- BSC85N1 FDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843228259 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen container IVD, additive/medium
BIOER Viral Transport Medium by Hangzhou Bioer Technology Co., Ltd. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
Sources (1)
- FDA UDI bbcf8982-9f10-45d7-b269-e4b77006d4a3 33 fields · synced May 30, 2026