Identity
- Trade Name
- Sample Preservative Fluid FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Device Name
- The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices. FDA UDI
- Model / Reference
- BSC82X1-A1 FDA UDI
- Description
- The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843228914 FDA UDI
- 510(k) Number
- K222771 FDA UDI
- FDA Product Code
- QBD FDA UDI
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2950 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
Yes
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
No
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 collection kit IVD, clinical
Sample Preservative Fluid by Hangzhou Bioer Technology Co., Ltd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
Sources (1)
- FDA UDI 99877d6f-ef9a-4484-8960-e34cca4fb999 34 fields · synced Jun 1, 2026