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STANDARD F Adeno Respi Ag FIA - ARCSA Registration 13bd5109c04958f34ad7e037859aa6fc

Access comprehensive regulatory information for STANDARD F Adeno Respi Ag FIA in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 13bd5109c04958f34ad7e037859aa6fc 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.

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ARCSA Official Data
III
13bd5109c04958f34ad7e037859aa6fc
STANDARD F Adeno Respi Ag FIA
ARCSA ID: 13bd5109c04958f34ad7e037859aa6fc
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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
13bd5109c04958f34ad7e037859aa6fc
Registration Date
December 08, 2022
Expiration Date
December 08, 2027
Product Use

THE STANDARD PRODUCT F ADENO RESPI FIA IS THE FLUORESCENT IMMUNOASSAY TO DETECT ADENOVIRUS INFECTION IN HUMANS THROUGH THE USE OF NASAL SWAB AND NASOPHARYNX, IDENTIFYING THE EXISTENCE OF ADENOVIRUS.

Manufacturer
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
Address
AV AMAZONAS N37-102 AND NATIONAL UNION OF JOURNALISTS
Phone
2266930