5f3978d99119216028d9f908e6051675
SARS-CoV-2 Rapid Antigen Test 2.0 Nasal
SD BIOSENSOR, INC.·III·Ecuador ARCSA·Registered March 24, 2023
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
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
Product use
QUALITATIVE DETECTION OF SARS-COV-2 NUCLEOCAPSID ANTIGEN PRESENT IN HUMAN NASAL SAMPLES.
About this record
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.