Identity
- Trade Name
- 96B Automated Viral RNA Isolation Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The 96B Automated Viral RNA Isolation Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or saliva). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. FDA UDI
- Model / Reference
- 96 Tests FDA UDI
- Description
- The 96B Automated Viral RNA Isolation Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or saliva). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. FDA UDI
Identifiers
- Catalog Number
- 3000000000145 FDA UDI
- Primary DI / UDI-DI
- 06973685471370 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
96B 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
Sources (1)
- FDA UDI 677c1307-51bc-40ae-8835-8f478a022704 35 fields · synced Jun 1, 2026