Identity
- Trade Name
- BIOER Sample Preservative Fluid 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
- BSC82X1-A1 FDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843228143 FDA UDI
- FDA Product Code
- QBD FDA UDI
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2950 FDA UDI
- Commercial Distribution
- Not 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
BIOER Sample Preservative Fluid by Hangzhou Bioer Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
Sources (1)
- FDA UDI 7bc7614e-6cc4-4385-be13-28df79c3f885 34 fields · synced May 30, 2026