Identity
- Trade Name
- Sentosa SA201 Real-Time PCR Instrument FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. FDA UDI
- Model / Reference
- 400125 FDA UDI
- Description
- The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. FDA UDI
Identifiers
- Catalog Number
- 400125 FDA UDI
- Primary DI / UDI-DI
- 08885013950021 FDA UDI
- FDA Product Code
- OOI 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Sentosa SA201 Real-Time PCR Instrument 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 2e1b24d1-953e-4dd3-b591-5eae392edbf3 34 fields · synced Jun 8, 2026