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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Ultrafast Twinblock 8 Wells Real Time PCR Instrument

Manufactured by Amazing Biotech (Shanghai) Co. Ltd., China - https://www.amazingbio.cn 

Device identification number
4080
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Biochip
Target type
RNA
Targets
spike protein/gene
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata
Pathogens detected
Influenza A, Influenza B, SARS-CoV-2
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-09-29 09:40:03 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Self Test
No
Reader Required
N.A.
Subcategory
Visualisation system
Method
RT-PCR
Measurement
Qualitative
Time
20 minutes
Subclass
N.A.
Detection Principle
N.A.
Analytical Sensitivity
100 copies/ml

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