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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

microproof SARS-CoV-2 Screening/Identification Kits

Manufactured by BIOTECON Diagnostics GmbH, Germany - www.bc-diagnostics.com/ 

Device identification number
531
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
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
240 minutes
LOD
7.5 cpr ((5-10 cpr))
Positive control
yes
Negative control
yes
Throughput
96 samples per run
Notes
Information provided by the manufacturer

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