BioCode SARS CoV-2 Assay kit
Manufactured by Applied BioCode, United States - apbiocode.com
Device identification number
1399
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
RNA Internal Control (RNA IC2: bacteriophageMS2) http://apbiocode.com/sars-cov-2.htm
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
0.0172 TCID50/ml
Clinical Sensitivity
98 %
Clinical Specificity
96.1 %
Throughput
23 hours
Notes
http://apbiocode.com/pdf/ABC_SARS-CoV-2_Package-Insert_Oct-2020.pdf
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