H.pylori Antigen Test Cassette (Feces) - ARCSA Registration 527d3bb8d9e7c2f5b99b4f2f9dea4d80
Access comprehensive regulatory information for H.pylori Antigen Test Cassette (Feces) in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 527d3bb8d9e7c2f5b99b4f2f9dea4d80 and manufactured by ACRO BIOTECH, INC.. The device was registered on May 17, 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
527d3bb8d9e7c2f5b99b4f2f9dea4d80
H.pylori Antigen Test Cassette (Feces)
ARCSA ID: 527d3bb8d9e7c2f5b99b4f2f9dea4d80
Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Commercial Name
19-931 IVD Reagents/Assay Kits, Immunoassay, Gastrointestinal Enzyme
Registration Information
Analysis ID
527d3bb8d9e7c2f5b99b4f2f9dea4d80
Registration Date
May 17, 2023
Expiration Date
May 17, 2028
Product Use
FOR THE QUANTITATIVE IN VITRO DETERMINATION OF H.PYLORI ANTIGEN IN HUMAN FAECES
Manufacturer
City
MONTCLAIR
Country
UNITED STATES
Address
4650 ARROW HIGHWAY, SUITE D-6 MONTCLAIR, CA 91763, U.S.A
Product Owner
Name
ACRO BIOTECH, INC.
Country
UNITED STATES
Authorized Representative