Dia-CV19-3 SARS-CoV-2 Direct OneStep RT-PCR Kit (S-/ORF1ab-Gene)
Manufactured by Diagen Biotechnologic Systems Inc., Turkey - www.diagen.com.tr/
Device identification number
1122
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-CV19-3_Direct_S-ORF1ab-Gene__v01_EN_100.pdf http://diagen.com.tr/assets/uploads/other/files/Covid/Diagen_COVID-19_Diagnostic_Products_3plex_EN_12.07.2020.pdf
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
Website: the kit includes the extraction step from the samples (10 minutes)
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