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STANDARD F PSA FIA - ARCSA Registration 31fdb624e6ee4758aeb6ca5eb3b881d1

Access comprehensive regulatory information for STANDARD F PSA FIA in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 31fdb624e6ee4758aeb6ca5eb3b881d1 and manufactured by SD BIOSENSOR, INC.. The device was registered on March 24, 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
31fdb624e6ee4758aeb6ca5eb3b881d1
STANDARD F PSA FIA
ARCSA ID: 31fdb624e6ee4758aeb6ca5eb3b881d1
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
SD Biosensor
Commercial Name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration Information
Analysis ID
31fdb624e6ee4758aeb6ca5eb3b881d1
Registration Date
March 24, 2023
Expiration Date
March 24, 2028
Product Use

THE STANDARD F PSA FIA IS AN IN VITRO DIAGNOSTIC KIT FOR MEASURING PROSTATE-SPECIFIC ANTIGEN IN PURE BLOOD, SERUM AND HUMAN BLOOD PLASMA. QUANTITATIVE PSA MEASUREMENT IS USEFUL IN THE DIAGNOSTIC EVALUATION OF PROSTATE CANCER, BENIGN PROSTATIC HYPERPLASIA (BPH), OR PROSTATITIS.

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