Identity
- Trade Name
- Sentosa SA201 HSV-1/2 PCR Test FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively. FDA UDI
- Model / Reference
- 300216 FDA UDI
- Description
- Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively. FDA UDI
Identifiers
- Catalog Number
- 300216 FDA UDI
- Primary DI / UDI-DI
- 08885013953664 FDA UDI
- FDA Product Code
- OQO FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Sentosa SA201 HSV-1/2 PCR Test by Vela Operations Singapore Pte. Ltd. — 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
- Vela Operations Singapore Pte. Ltd.
Sources (1)
- FDA UDI 2d5c105b-d780-4747-8ef9-d6b83c532636 34 fields · synced May 31, 2026