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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-COV-2 RT-qPCR Assay

Manufactured by Acro Biotech Inc, United States - www.acrobiotech.com 

Device identification number
1693
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
100 minutes
LOD
200 AU
Positive control
RAN Pseudovirus
Negative control
DEPC-Treated Water
Analytical Sensitivity
100 %
Analitical Specificity
99.14 %
Clinical Sensitivity
100 %
Clinical Specificity
99.14 %
Throughput
96 samples/run
Notes
https://www.acrobiotech.com/covid-19-tests

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