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One Step H. pylori Antigen Test Device (Feces ) Ref.IHP-602 - ARCSA Registration 7c807c5340b075f841c509da0fd7f2ed

Access comprehensive regulatory information for One Step H. pylori Antigen Test Device (Feces ) Ref.IHP-602 in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 7c807c5340b075f841c509da0fd7f2ed and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The device was registered on January 05, 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
II
7c807c5340b075f841c509da0fd7f2ed
One Step H. pylori Antigen Test Device (Feces ) Ref.IHP-602
ARCSA ID: 7c807c5340b075f841c509da0fd7f2ed
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
SHREDDED
Commercial Name
19-466 IVD Reagents/Kits, Serology, Rapid Assay
Sterilization Method
ANALYTICAL METHODOLOGY: SEPARATION. CHROMATOGRAPHY
Registration Information
Analysis ID
7c807c5340b075f841c509da0fd7f2ed
Registration Date
January 05, 2022
Expiration Date
January 05, 2027
Creation Date
May 01, 2022
Product Use

SINGLE-PASS PLATE EXAMINATION OF H. PYLORI ANTIGEN (FECES) IS A CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF H. PYLORI ANTIGEN IN HUMAN STOOL SAMPLES AS AN AID IN THE DIAGNOSIS OF H. PYLORI INFECTION.

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