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SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test, Ref: ISIR-ACO535 - ARCSA Registration d2812ffeb74a2ba8bb4c12c3f5229ee8

Access comprehensive regulatory information for SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test, Ref: ISIR-ACO535 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID d2812ffeb74a2ba8bb4c12c3f5229ee8 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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III
d2812ffeb74a2ba8bb4c12c3f5229ee8
SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test, Ref: ISIR-ACO535
ARCSA ID: d2812ffeb74a2ba8bb4c12c3f5229ee8
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Commercial Name
19-937 IVD Reagents/Assay Kits, Immunoassay, Rapid
Registration Information
Analysis ID
d2812ffeb74a2ba8bb4c12c3f5229ee8
Registration Date
January 25, 2023
Expiration Date
January 25, 2028
Product Use

FOR THE QUALITATIVE DETECTION OF SARS-COV-2, INFLUENZA A, INFLUENZA B, RESPIRATORY SYNCYTIAL VIRUS (RSV) ANTIGENS, IN NASOPHARYNGEAL SWAB SPECIMENS

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