SARS-CoV-2 Real Time PCR LAB-KIT
Manufactured by BioMaxima SA, Poland - www.biomaxima.com/
Device identification number
89
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
Declared as "Validated and registered in URPL" (Poland)
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
62 minutes
LOD
? 10 RNA copies
Positive control
positive control, not specified
Negative control
negative control, not specified
Analytical Sensitivity
99 % ((> 99%))
Analytical Specificity
99 % ((> 99%))
Throughput
Single tubes
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