VitaPCR Flu A&B Assay

Primary DI

04719878570022

Basic UDI-DI Code

B-04719878570022

Reference

PCRAE0103

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch

The VitaPCR™ Flu A&B Assay performed on the VitaPCR™ Instrument is a rapid molecular in vitro diagnostic test utilizing a real-time reverse transcription polymerase chain reaction (rRT-PCR) amplification technology. It used for the qualitative detection and differentiation of influenza A and influenza B viral RNAs in nasal and nasopharyngeal swabs collected from individuals with signs and symptoms of respiratory infection. It is intended as an aid in the differential diagnosis of common influenza A and influenza B viral infections in humans and is not intended to detect influenza C.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).