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One Step H. pylori Test Device (Serum / Plasma ) Ref.IHP-302 - ARCSA Registration b086082440d3afe5a012cd656f3a58aa

Access comprehensive regulatory information for One Step H. pylori Test Device (Serum / Plasma ) Ref.IHP-302 in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID b086082440d3afe5a012cd656f3a58aa and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The device was registered on February 04, 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
b086082440d3afe5a012cd656f3a58aa
One Step H. pylori Test Device (Serum / Plasma ) Ref.IHP-302
ARCSA ID: b086082440d3afe5a012cd656f3a58aa
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
SHREDDED
Commercial Name
19-348 Reagents/Kits for IVD Assays, Serology, Bacteria, Helicobacter Pilori, Antibodies
Sterilization Method
ANALYTICAL METHODOLOGY: SEPARATION. CHROMATOGRAPHY
Registration Information
Analysis ID
b086082440d3afe5a012cd656f3a58aa
Registration Date
February 04, 2022
Expiration Date
February 04, 2027
Creation Date
April 02, 2022
Product Use

THE SINGLE-STEP PLATE (SERUM/PLASMA) H. PYLORI TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF SERUM OR PLASMA H. PYLORI ANTIBODIES TO AID IN THE DIAGNOSIS OF H. PYLORI INFECTIONS.

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