Identity
- Trade Name
- 96A Automated Viral RNA Isolation Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technology for automated isolation and purification of RNA from biological samples. The product is intended to be used by professional users that are trained in molecular biological techniques. FDA UDI
- Model / Reference
- 96 Tests FDA UDI
- Description
- The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technology for automated isolation and purification of RNA from biological samples. The product is intended to be used by professional users that are trained in molecular biological techniques. FDA UDI
Identifiers
- Catalog Number
- 3000000000012 FDA UDI
- Primary DI / UDI-DI
- 06973685471028 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
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
Yes
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
No
FDA UDI
96A 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 91910c92-7fd7-4c11-8f05-ff926d17f0ee 35 fields · synced Jun 8, 2026