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SARS-CoV-2 Rapid Antigen Test 2.0 - ARCSA Registration c48e99a154ae0d020b0fe207fa436972

Access comprehensive regulatory information for SARS-CoV-2 Rapid Antigen Test 2.0 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID c48e99a154ae0d020b0fe207fa436972 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
c48e99a154ae0d020b0fe207fa436972
SARS-CoV-2 Rapid Antigen Test 2.0
ARCSA ID: c48e99a154ae0d020b0fe207fa436972
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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
c48e99a154ae0d020b0fe207fa436972
Registration Date
March 24, 2023
Expiration Date
March 24, 2028
Product Use

QUALITATIVE DETECTION OF SARS-COV-2 NUCLEOCAPSID ANTIGEN PRESENT IN HUMAN NASOPHARYNGEAL SWAB 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
Address
AV SIMON BOLIVAR N/A Y VIA A NAYON
Phone
3997100