PathoDetect COVID-19 Qualitative PCR Kit
Manufactured by Mylab Discovery Solutions Pvt. Ltd., India - https://mylabdiscoverysolutions.com/
Device identification number
288
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Cartridge
Target type
Nucleic acid
Specimen
Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
180 minutes
Subclass
JRC-S
LOD
1 AU
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Clinical Sensitivity
95 %
Clinical Specificity
100 %
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