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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Dia-CV19-2 SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-Gene)

Manufactured by Diagen Biotechnologic Systems Inc., Turkey - www.diagen.com.tr/ 

Device identification number
540
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://diagen.com.tr/assets/uploads/other/files/Covid/Dia-CV19-2_OneStep__S-ORF1ab-Gene__v01_EN_100.pdf http://diagen.com.tr/en/products/human-diagnostic-products/molecular-products/covid-19
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
52 minutes
Positive control
S-gene + ORF1ab-gene + internal control (GAPDH gene)
Negative control
Nuclease-free water
Throughput
100 AU
Notes
There is NO isolation step in the kit, it works with isolated RNA.; http://diagen.com.tr/en/products/human-diagnostic-products/molecular-products/covid-19#gallery-2

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