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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RapidScript SARS-CoV-2 Assay

Manufactured by MP Biomedicals, Germany - https://www.mpbio.com/eu/ 

Device identification number
1127
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Nasopharyngeal swabs; Oropharyngeal swabs https://www.mpbio.com/eu/covid19-essential-products/rapidscript
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
31 minutes
LOD
2.5 copies/μl
Positive control
SARS-CoV-2 Nucleocapsid Markers (N1 and N2); RNase P
Throughput
400 reactions
Notes
https://www.mpbio.com/media/productattachment/LS072020-EN-RapidScript-SARS-CoV-2-Assay-11MSTP400-Manual.pdf relative quantification

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