SARS-CoV-2 Rapid Antigen Test 2.0 Nasal - ARCSA Registration 5f3978d99119216028d9f908e6051675
Access comprehensive regulatory information for SARS-CoV-2 Rapid Antigen Test 2.0 Nasal in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 5f3978d99119216028d9f908e6051675 and manufactured by SD BIOSENSOR, INC.. The device was registered on March 24, 2023.
This page provides complete registration details including product type (In Vitro Diagnostic), 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
5f3978d99119216028d9f908e6051675
SARS-CoV-2 Rapid Antigen Test 2.0 Nasal
ARCSA ID: 5f3978d99119216028d9f908e6051675
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
ROCHE
Commercial Name
64787-SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid
Registration Information
Analysis ID
5f3978d99119216028d9f908e6051675
Registration Date
March 24, 2023
Expiration Date
March 24, 2028
Product Use
QUALITATIVE DETECTION OF SARS-COV-2 NUCLEOCAPSID ANTIGEN PRESENT IN HUMAN NASAL SAMPLES.
Manufacturer
City
CHEONGJU-SI
Country
KOREA, REPUBLIC OF
Address
74 OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU
Product Owner
Name
SD BIOSENSOR, INC.
Country
KOREA, REPUBLIC OF
Authorized Representative