Sentosa SA HSV1/2 PCR Test (4x24)
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Basic Information
- Primary DI
- D-888501395SSAHSV12QLTV8
- Basic UDI-DI Code
- B-888501395SSAHSV12QLTV8
- Reference
- 300064
- 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 PCR Test (4x24) is a multiplex, real-time PCR-based in vitro diagnostic test intended for use in the detection and differentiation of Herpes Simplex Virus 1&2 (HSV1/2) DNA in genital or oral swabs in UTM, EDTA plasma, serum and cerebrospinal fluid (CSF) from patients with signs and symptoms of HSV infections. This in vitro diagnostic test is validated to be performed on the automated Sentosa® SX101 instrument, using the Sentosa® SX Virus Total Nucleic Acid Kit v2.0 (4x24), in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040311 | HSV - NA REAGENTS |
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