geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B)
Manufactured by Genmark Saglik Urunleri Ith. Ihr. ve Tic. Ltd Sti. - www.genmark.com.tr
Device identification number
1221
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-03-30 06:27:58
Comments
Conformity 95.09%
Assay Type
Nucleic acid-PCR
Time
46 minutes
LOD
500 copies/ml ()
Positive control
Synthetic Nucleic Acid (Ultramer)
Negative control
RNase Free Water
Analytical Sensitivity
95 % ()
Analitical Specificity
96 % ()
Clinical Sensitivity
95 % ()
Clinical Specificity
96 % ()
Throughput
96 samples/run ( samples per run)
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