Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test

Primary DI

08885013953954

Basic UDI-DI Code

B-08885013953954

Reference

111267

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test is a real-time PCR-based in vitro diagnostic test for the qualitative detection and differentiation of Influenza A, Influenza B and 2009 H1N1 (Pandemic Influenza A H1N1nv) in nasal swab and nasopharyngeal swab samples from human patients with signs and symptoms of respiratory tract infections. This diagnostic test kit is configured for use with the Sentosa SX101 nucleic acid extraction platform, with the Sentosa SX Virus Total Nucleic Acid Kit, in conjunction with the Rotor-Gene Q MDX 5plex HRM system. Test results can be used as supplementary data for diagnosis, or large scale screening of Influenza infection in cases of a flu outbreak. Negative results do not preclude Influenza infection and should not be used as a sole basis for treatment and other patient management decisions.

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