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HBsAg Hepatitis B Surface Antigen Whole Blood/ Serum/Plasma Ref. IHBsg-402 - ARCSA Registration 9045e86f4a72165413e9ea4a99612f77

Access comprehensive regulatory information for HBsAg Hepatitis B Surface Antigen Whole Blood/ Serum/Plasma Ref. IHBsg-402 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 9045e86f4a72165413e9ea4a99612f77 and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The device was registered on July 19, 2022.

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
9045e86f4a72165413e9ea4a99612f77
HBsAg Hepatitis B Surface Antigen Whole Blood/ Serum/Plasma Ref. IHBsg-402
ARCSA ID: 9045e86f4a72165413e9ea4a99612f77
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Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
SHREDDED
Commercial Name
19-472 IVD Reagents/Kits, Serology, Rapid Assay, Virus, Hepatitis
Sterilization Method
ANALYTICAL METHODOLOGY: SEPARATION. CHROMATOGRAPHY
Registration Information
Analysis ID
9045e86f4a72165413e9ea4a99612f77
Registration Date
July 19, 2022
Expiration Date
July 19, 2027
Creation Date
July 19, 2022
Product Use

IT IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGENS IN WHOLE BLOOD, SERUM OR PLASMA.

Manufacturer
City
HANGZHOU
Country
CHINA
Address
198 12TH STREET EAST, HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA, HANGZHOU, 310018, P.R. CHINA
Product Owner
Name
ABON BIOPHARM (HANGZHOU) CO., LTD
Country
CHINA
Authorized Representative
Address
AV. REPUBLICA DEL SALVADOR N34-493 AND PORTUGAL GIBRALTAR BUILDING 10TH FLOOR
Phone
980670023