Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

MassARRAY SARS-CoV-2 Panel

Manufactured by AgenaBioscience,Inc, United States - agenabio.com 

Device identification number
1396
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
reverse transcription (RT-PCR)/MALDI-TOF test; positive control: Twist Bioscience Synthetic SARS-CoV-2 RNA Control 1 #102019; extraction control: MS2 Phage RNA https://agenabio.com/products/panel/coronavirus-sars-cov-2-detection-panel/
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
82 minutes
LOD
2.5 copies/μl
Positive control
Synthetic SARS-CoV-2 RNA Control
Negative control
Nuclease-free water
Clinical Sensitivity
95 %
Clinical Specificity
100 %
Notes
https://agenabio.com/wp-content/uploads/2020/11/MA_SC2_Panel_EUA_IFU-CUS-001_R06.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