Identity
- Trade Name
- Q-Vera Prima 96 qPCR Instrument FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only. FDA UDI
- Model / Reference
- 96-well, 0.2 mL block FDA UDI
- Description
- For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955792700864 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q-Vera Prima 96 qPCR Instrument by Sansure Biotech Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
Sources (1)
- FDA UDI 9c791f5e-567a-4947-80b0-0eac2574a612 34 fields · synced May 31, 2026