VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set

Primary DI

04719878570534

Basic UDI-DI Code

B-04719878570534

Reference

PCRAD1106

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch

The VitaSIRO solo™ SARS-CoV-2/Flu/RSV External Control Set is an in vitro diagnostic external run control intended to be used as an aid to verify the performance of VitaSIRO solo™ SARS-CoV-2/Flu/RSV assay. The regular use of external run controls helps laboratories monitor daily test variations, assess the performance of different test kit lots, track individual operator variations, and identify increases in random or systemic errors. The VitaSIRO solo™ SARS-CoV-2/Flu/RSV External Control Set contains in vitro transcribed RNA fragments and should be run in a manner identical to that used for clinical specimens.

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