Identity
- Trade Name
- Babio FDA UDI
- Generic Name
- Cytology specimen container IVD, transport buffer FDA UDI
- Device Name
- Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It measures viral particles in the samples using molecular or antigen assays. Not intended for internal use. FDA UDI
- Model / Reference
- VTM FDA UDI
- Description
- Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It measures viral particles in the samples using molecular or antigen assays. Not intended for internal use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975025173814 FDA UDI
- FDA Product Code
- QMC FDA UDI
- GMDN Term
- Cytology specimen container IVD, transport buffer 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cytology specimen container IVD, transport buffer
Babio by Jinan Babio Biotechnology 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
- Jinan Babio Biotechnology Co., Ltd.
Sources (1)
- FDA UDI 48b8585d-f130-423b-b361-b672bb7e6828 33 fields · synced May 30, 2026