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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

iNADx Multiplex III COVID-19 RT-qPCR Kit

Manufactured by SACEM Hayat Teknolojileri A.S., Turkey - www.sacem.com.tr/ 

Device identification number
1836
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Nasal aspiration, Nasopharyngeal swab, Sputum, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The detection of SARS-CoV-2 RNA is done in single tube in which human RNase P is simultaneously detected. COVID-19 real-time PCR assay utilizes human RNase P as an internal control, which controls for target isolation and amplification. The oligonucleotide primers and probes for detection of SARS-CoV-2 were selected from regions of the virus conserved region of N gene. The kit is designed for specific detection of the SARS-CoV-2 (primer/probe sets).
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Positive control
RNase P

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