Identity
- Trade Name
- 96A Viral RNA Auto Extraction & Purification Kit FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- The Viral RNA Auto Extraction & Purification Kit utilize 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/Kit FDA UDI
- Description
- The Viral RNA Auto Extraction & Purification Kit utilize 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
- 3103010059 FDA UDI
- Primary DI / UDI-DI
- 06973685471011 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid sample preparation instrument 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
Yes
FDA UDI
96A Viral RNA Auto Extraction & Purification 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 b670ec78-9aab-4208-b17e-2fccdfdb45d5 35 fields · synced Jun 1, 2026