STANDARD F PSA FIA
- Risk class
- III
- Product type
- In Vitro Diagnostic
- Brand name
- SD Biosensor
- Commercial name
- 19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
- Analysis ID
- 31fdb624e6ee4758aeb6ca5eb3b881d1
- Registration date
- March 24, 2023
- Expiration date
- March 24, 2028
- City
- CHUNGCHEONGBUK-DO
- Country
- KOREA, REPUBLIC OF
- Address
- 74, OSONGSAENGMYEONG 4-RO, OSONG-EUP, HEUNGDEOK-GU, CHEONGJU-SI, CHUNGCHEONGBUK-DO 28161, REPUBLIC OF KOREA
- Name
- SD BIOSENSOR, INC.
- Country
- KOREA, REPUBLIC OF
- Name
- SIMED S. A.
- Address
- AV AMAZONAS N37-102 AND NATIONAL UNION OF JOURNALISTS
- Phone
- 2266930
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.
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.