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STANDARD F HCV Ab FIA - ARCSA Registration f2a5f5665ae32f4bbbadb2ff0f2f26dc

Access comprehensive regulatory information for STANDARD F HCV Ab FIA in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID f2a5f5665ae32f4bbbadb2ff0f2f26dc and manufactured by SD BIOSENSOR, INC.. The device was registered on April 12, 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.

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ARCSA Official Data
III
f2a5f5665ae32f4bbbadb2ff0f2f26dc
STANDARD F HCV Ab FIA
ARCSA ID: f2a5f5665ae32f4bbbadb2ff0f2f26dc
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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
f2a5f5665ae32f4bbbadb2ff0f2f26dc
Registration Date
April 12, 2023
Expiration Date
April 12, 2028
Product Use

THE STANDARD F HCV AB FIA PRODUCT IS A FLUORESCENT IMMUNOASSAY FOR DETECTING HCV-SPECIFIC ANTIBODIES PRESENT IN HUMAN SERUM, WHOLE BLOOD, AND PLASMA SAMPLES IN PATIENTS WITH SYMPTOMS OF HCV INFECTION.

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