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VivaDiag TM COVID-19 IgM/IgG Rapid Test - ARCSA Registration 43b108ab7fee003ebbedae6943718017

Access comprehensive regulatory information for VivaDiag TM COVID-19 IgM/IgG Rapid Test in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 43b108ab7fee003ebbedae6943718017 and manufactured by VIVACHECK BIOTECH. The device was registered on April 13, 2020.

This page provides complete registration details including product type (No Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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ARCSA Official Data
III
43b108ab7fee003ebbedae6943718017
VivaDiag TM COVID-19 IgM/IgG Rapid Test
ARCSA ID: 43b108ab7fee003ebbedae6943718017
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Device Classification
Risk Class
III
Product Type
No Invasive
Commercial Name
IVD Reagents/Assays, Molecular Assay, Infection, Virus, Severe Acute Respiratory Syndrome Coronavirus, RNA
Registration Information
Analysis ID
43b108ab7fee003ebbedae6943718017
Registration Date
April 13, 2020
Expiration Date
April 13, 2025
Product Use

IT'S A LATERAL FLOW CHROMATOGRAPHIC IMMUNOASSAY FOR DETECTION QUALITATIVE IGG AND IGM ANTIBODIES AGAINST 2019-NCOV IN A FINGERSTICK WHOLE BLOOD SAMPLE.

Manufacturer
City
HANGZHOU
Country
CHINA
Address
LEVEL 2,BLOCK 2 , 146 EAST CHAOFENG RD.,YUHANG ECONOMY DEVELOPMENT ZONE,HANGZHOU 311100 ,CHINA
Product Owner
Name
VIVACHECK BIOTECH
Country
CHINA
Authorized Representative
Address
MARQUEZ DE VARELA N21-97 AV AMERICA / AV AMERICA 1143 AND AV UNIVERSITARIA
Phone
3216240