ExAmplex Influenza A/B SARS-CoV-2 PCR kit
Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en
Device identification number
1450
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
95 minutes
LOD
6.79 copies/reaction
Positive control
N gene sequence of SARS-CoV-2
Negative control
Nuclease-free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
other
Notes
Manual NAT
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