5688b371645c0afbfd51f3bca280ca78

STANDARD F Strep A Ag FIA

SD BIOSENSOR, INC.·II·Ecuador ARCSA·Registered March 07, 2023
Device classification
Risk class
II
Product type
In Vitro Diagnostic
Brand name
SD Biosensor
Commercial name
19-041 IVD Reagents/Testing Kits, Serology, Bacteria
Registration information
Analysis ID
5688b371645c0afbfd51f3bca280ca78
Registration date
March 07, 2023
Expiration date
March 07, 2028
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

STANDARD F STREP A AG FIA IS A FLUORESCENT IMMUNOASSAY FOR THE DETECTION OF GROUP A STREPTOCOCCUS ANTIGEN (STREP A) PRESENT IN PHARYNGEAL SPECIMENS FROM PATIENTS WITH CLINICAL SYMPTOMS.

About this record

Access comprehensive regulatory information for STANDARD F Strep A Ag FIA in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 5688b371645c0afbfd51f3bca280ca78 and manufactured by SD BIOSENSOR, INC.. The device was registered on March 07, 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.