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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent

Manufactured by GeneReach Biotechnology Corporation, Taiwan ROC - http://www.genereach.com/index.php 

Device identification number
180
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
85 minutes
LOD
60000 copies/ml
Positive control
Positive control not specified
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
96.8 %
Clinical Specificity
97.1 %
Notes
https://www.genereach.com/index.php?func=product&action=add_item&item_no=209

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