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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VivaDiag SARS-CoV-2 Ag Saliva Rapid Test

Manufactured by VivaChek Biotech (Hangzhou) Co., Ltd, China - www.vivachek.com 

Device identification number
1980
CE Marking
Yes
HSC common list (RAT)
×No
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
VivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test is registered in Netherlands by its notified noby : Lotus NL B.V. This is the content of certificat : On November11, 2020, I received your notification under Article 4, paragraph 1 of the Dutch Decree for in-vitro diagnostics (DIVD), under the company name VivaChek Biotech (Hangzhou) Co., Ltd. with European authorized Lotus NL B.V. to sell the following in-vitro diagnostic products in the European market. The products are registered as in-vitro diagnostics under serial number: VivaDiag SARS-CoV-2 Ag Saliva Rapid Test VCD17 (geen merknaam) (NL-CA002-2020-54216) Best regards, Yujun
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
15 minutes
LOD
75.5 AU
Calibration
Not evaluated
Crossreactivity
Not evaluated
Precision
Not evaluated
Accuracy
99.5 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.26 %
Clinical Specificity
99.99 % ((>99.99%))
Type of antigen
Nucleoprotein

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