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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



PerkinElmer New Coronavirus Nucleic Acid Detection Kit

Manufactured by PerkinElmer Inc, United States - www.perkinelmer.com/ 

Device identification number
743
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
minutes
LOD
20 copies/μl (using a 400 µL sample)
Positive control
ORF1ab and N genes
Notes
https://perkinelmer-appliedgenomics.com/home/products/sars-cov-2-real-time-rt-pcr-assay-ce-ivd/

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