Identity
- Trade Name
- 32B Automated Viral RNA Isolation Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- 32B Automated Viral RNA Isolation Kit is intended for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs and saliva ) by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained. FDA UDI
- Model / Reference
- 64 Tests FDA UDI
- Description
- 32B Automated Viral RNA Isolation Kit is intended for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs and saliva ) by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained. FDA UDI
Identifiers
- Catalog Number
- 3000000000147 FDA UDI
- Primary DI / UDI-DI
- 06973685471363 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
32B Automated Viral RNA Isolation Kit by 3D Biomedicine Science & Technology Co., Limited — Class I — FDA UDI — listed in FDA GUDID
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
- 3D Biomedicine Science & Technology Co., Limited
Sources (1)
- FDA UDI 147a87b1-5eea-4f70-b3e6-bde3e2d078cf 35 fields · synced May 31, 2026