COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

IQ REAL™ SARS-CoV-2 Qualitative System

Manufactured by GeneReach Biotechnology Corporation, Taiwan ROC - http://www.genereach.com/index.php

Device identification number

2831

CE Marking

✓Yes

HSC common list (RAT)

×No

Target type

Nucleic acid

Specimen

Oropharyngeal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

None

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Measurement

Qualitative

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements