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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines)

Manufactured by KRISHGEN BioSystems, United States - www.krishgen.com/ 

Device identification number
250
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Subclass
NIID_2019_nCOV_N
Positive control
Positive control (non-infectious DNA), Human specimen extraction Control (HSC)
Notes
https://krishgen.com/idh9eknj/uploads/products/1585660551KBRT010_SARS-Cov-2%20Coronavirus%20Real-time%20RT-PCR_RT-qPCR_Detection_Kit_ver2.2.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