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de81d3805c424cc63be8b888cfd3dfb5

STANDARD F RSV Ag FIA

SD BIOSENSOR, INC.·III·Ecuador ARCSA·Registered December 08, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
SD BIOSENSOR
Commercial name
17-077 IVD Reagents/Testing Kits, Serology, Viruses
Registration information
Analysis ID
de81d3805c424cc63be8b888cfd3dfb5
Registration date
December 08, 2022
Expiration date
December 08, 2027
Manufacturer
Name
SD BIOSENSOR, INC.
City
CHUNGCHEONGBUK-DO
Country
KOREA, REPUBLIC OF
Address
74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO 28161, REPUBLIC OF KOREA
Product owner
Name
SD BIOSENSOR, INC.
Country
KOREA, REPUBLIC OF
Authorized representative
Name
SIMED S. A.
Address
AV AMAZONAS N37-102 AND NATIONAL UNION OF JOURNALISTS
Phone
2266930
Product use

STANDARD F RSV AG FIA IS A FLUORESCENT IMMUNOASSAY FOR DETECTING RSV ANTIGEN PRESENT IN SAMPLES FROM A NASOPHARYNGEAL SWAB OR NASOPHARYNGEAL ASPIRATION/LAVAGE FROM PATIENTS WITH SYMPTOMS OF A VIRAL RESPIRATORY INFECTION.

About this record

Access comprehensive regulatory information for STANDARD F RSV Ag FIA in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID de81d3805c424cc63be8b888cfd3dfb5 and manufactured by SD BIOSENSOR, INC.. The device was registered on December 08, 2022.

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.