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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VereCoV OneMix Detection Kit for VerePLEX Biosystem

Manufactured by Veredus Laboratories Pte Ltd., Singapore - www.vereduslabs.com/ 

Device identification number
419
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test integrates PCR amplification and microarray for rapid qualitative detection of 2019-nCoV IFU will be provided upon request
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
120 minutes
LOD
10 copies/μl
Positive control
N1 Positive Control
Analysis of cross reactivity
detects SARS-CoV. Without cross-reactivity with other coronaviruses such as OC43, 229E, KhU1, NL63
Throughput
lab-on-chip
Notes
https://vereduslabs.com/wordpress/wp-content/uploads/2020/03/VereCoV-Press-Release_30-Mar_CE-IVD.pdf

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