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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CareStart COVID-19 MDx RT-PCR

Manufactured by Access Bio, Inc, United States - www.accessbio.net/ 

Device identification number
760
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
samples: upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage https://accessbiodiagnostics.net/covid-19-mdx-rt-pcr/
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
83 minutes
Subclass
WHO-1
LOD
10 copies/reaction
Positive control
N gene, RdRP gene, and MS2
Negative control
nuclease free water
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
100 tests
Notes
https://accessbiodiagnostics.net/wp-content/uploads/2020/07/EUA-access-carestart-ifu.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