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STANDARD F iFOB FIA - ARCSA Registration 67a6c43791a646a02e4286596d647ef6

Access comprehensive regulatory information for STANDARD F iFOB FIA in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 67a6c43791a646a02e4286596d647ef6 and manufactured by SD BIOSENSOR, INC.. The device was registered on April 04, 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
II
67a6c43791a646a02e4286596d647ef6
STANDARD F iFOB FIA
ARCSA ID: 67a6c43791a646a02e4286596d647ef6
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
SD BIOSENSOR
Commercial Name
17-410 IVD Reagents/Testing Kits, Clinical Chemistry, Rapid Assay, Feces, Occult Blood
Registration Information
Analysis ID
67a6c43791a646a02e4286596d647ef6
Registration Date
April 04, 2023
Expiration Date
April 04, 2028
Product Use

THE STANDARD F IFOB FIA IS A FECAL IMMUNOCHEMICAL TEST (PIF. FECAL IMMUNOCHEMICAL TEST-FIT (FECAL IMMUNOCHEMICAL TEST-FIT) FOR DETECTION AND QUANTIFICATION OF HEMOGLOBIN (HB) IN STOOL SAMPLES. THE QUANTITATIVE FOB TEST CAN BE USED TO DETECT EXCESSIVE BLEEDING IN THE LOWER GASTROINTESTINAL CANAL (INFLAMMATORY BOWEL DISEASE, COLORECTAL CANCER CONTROL PROGRAMS).

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