fca92a3f50ce57d7bf0b5f455f090d23

STANDARD F Zika Ag FIA

SD BIOSENSOR, INC.·III·Ecuador ARCSA·Registered December 13, 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
fca92a3f50ce57d7bf0b5f455f090d23
Registration date
December 13, 2022
Expiration date
December 13, 2027
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
Product use

THE STANDARD F ZIKA AG FIA TEST IS A FLUORESCENCE IMMUNOASSAY FOR THE DETECTION OF ZIKA-SPECIFIC ANTIGEN PRESENT IN SERUM, PLASMA, OR HUMAN WHOLE BLOOD SAMPLES FROM PATIENTS WITH SYMPTOMS OF ZIKA INFECTION.

About this record

Access comprehensive regulatory information for STANDARD F Zika Ag FIA in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID fca92a3f50ce57d7bf0b5f455f090d23 and manufactured by SD BIOSENSOR, INC.. The device was registered on December 13, 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.