Sentosa SA HSV1/2 Quantitation Standards (2x13)
Basic Information
- Primary DI
- 08885013953305
- Basic UDI-DI Code
- B-08885013953305
- Reference
- 300071
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
The Sentosa® SA HSV1/2 Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection, differentiation and quantitation of Herpes simplex virus 1 and 2 (HSV1/2) DNA using Sentosa® SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For swab in UTM, human EDTA plasma, serum and cerebrospinal fluid (CSF) samples, Sentosa® SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for DNA extraction; and for human EDTA whole blood samples, Sentosa® SX Whole Blood Kit is used for DNA extraction. The Sentosa® SA HSV1/2 Quantitative PCR Test is intended for use in the detection, differentiation and quantitation of HSV1/2 DNA from symptomatic patients as an aid in HSV1/2 diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with HSV1/2 infection. The results from the Sentosa® SA HSV1/2 Quantitative PCR Test must be interpreted within the context of all relevant clinical and laboratory findings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040311 | HSV - NA REAGENTS |
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