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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Alinity m SARS-CoV-2 AMP Kit

Manufactured by Abbott Molecular Inc, United States - www.molecular.abbott 

Device identification number
1042
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
115 minutes
LOD
100 cpm
Positive control
Positive control included in SARS-CoV-2 CTRL kit. Internal control included in every reaction.
Negative control
Negative control available as part of SARS-CoV-2 CTRL kit.
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
96.5 %
Throughput
96 samples/run

Related Scientific Literature

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