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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive)

Manufactured by Zhejiang Anji Saianfu Biotech Co. Ltd., China - www.reopentest.com 

Device identification number
1845
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Oropharyngeal swab, Sputum, Throat secretion, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
BfArM Listed, PEI evaluated
Assay Type
Immuno-Antigen
Method
Immunoassay

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