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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

MD-Bio BCC19 Test Kit

Manufactured by MD-Bio Inc., United States - www.mdbio.com 

Device identification number
2952
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Nucleic acid
Targets
envelope protein/gene, nucleocapsid protein/gene
Specimen
Nasal swab, Nasopharyngeal swab
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The BCC19 test kit has an FDA EUA along with CE certification.
Assay Type
Nucleic acid-Other
Self Test
No
Reader Required
No
Method
LAMP
Measurement
Qualitative
Time
30 minutes
LOD
75 %
Positive control
Required every heat cycle
Negative control
Required every heat cycle
Analytical Sensitivity
99 %
Analytical Specificity
100 %
Clinical Sensitivity
98 %
Clinical Specificity
100 %
Throughput
96 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