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SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test. Ref: IRT-ACO545 - ARCSA Registration af67c44fe036b75f2924a14ffd977509

Access comprehensive regulatory information for SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test. Ref: IRT-ACO545 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID af67c44fe036b75f2924a14ffd977509 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
af67c44fe036b75f2924a14ffd977509
SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test. Ref: IRT-ACO545
ARCSA ID: af67c44fe036b75f2924a14ffd977509
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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
af67c44fe036b75f2924a14ffd977509
Registration Date
January 25, 2023
Expiration Date
January 25, 2028
Product Use

FOR QUALITATIVE DETECTION OF SARS-COV-2, INFLUENZA A, INFLUENZA B, RESPIRATORY SYNCYTIAL VIRUS (RSV), AND ADENOVIRUS 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