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SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test. Ref: IRT-ACO555 - ARCSA Registration 3e87b492bb17aef6a99e40187344d6dd

Access comprehensive regulatory information for SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test. Ref: IRT-ACO555 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 3e87b492bb17aef6a99e40187344d6dd 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
3e87b492bb17aef6a99e40187344d6dd
SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test. Ref: IRT-ACO555
ARCSA ID: 3e87b492bb17aef6a99e40187344d6dd
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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
3e87b492bb17aef6a99e40187344d6dd
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), ADENOVIRUS, AND MYCOPLASMA PNEUMONIAE 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