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Dust Mite IgE Rapid Test Cassette. Ref: ODME-ACO402 - ARCSA Registration d9522179d70494dd66de3f5fb2aa3c96

Access comprehensive regulatory information for Dust Mite IgE Rapid Test Cassette. Ref: ODME-ACO402 in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID d9522179d70494dd66de3f5fb2aa3c96 and manufactured by ACRO BIOTECH, INC.. The device was registered on January 25, 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
d9522179d70494dd66de3f5fb2aa3c96
Dust Mite IgE Rapid Test Cassette. Ref: ODME-ACO402
ARCSA ID: d9522179d70494dd66de3f5fb2aa3c96
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Commercial Name
19-937 IVD Reagents/Assay Kits, Immunoassay, Rapid
Registration Information
Analysis ID
d9522179d70494dd66de3f5fb2aa3c96
Registration Date
January 25, 2023
Expiration Date
January 25, 2028
Product Use

FOR THE QUALITATIVE DETECTION OF HUMAN IGE ANTIBODIES AGAINST DUST MITES IN WHOLE BLOOD, SERUM OR PLASMA SAMPLE.

Manufacturer
City
MONTCLAIR
Country
UNITED STATES
Address
4650 ARROW HIGHWAY SUITE D6, MONTCLAIR, CA 91763
Product Owner
Name
ACRO BIOTECH, INC.
Country
UNITED STATES
Authorized Representative
Address
URB BELLAVISTA ALTA 3RD TRANSVERSAL N61-37 AND SABANILLA
Phone
2293537