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PSA Rapid Test Cassette, Code TPS-Q402 - ARCSA Registration 43f17b74643e363d84b6829addeed809

Access comprehensive regulatory information for PSA Rapid Test Cassette, Code TPS-Q402 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 43f17b74643e363d84b6829addeed809 and manufactured by ACRO BIOTECH, INC.. The device was registered on July 06, 2022.

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
III
43f17b74643e363d84b6829addeed809
PSA Rapid Test Cassette, Code TPS-Q402
ARCSA ID: 43f17b74643e363d84b6829addeed809
Local name: PSA Rapid Test Cassette, Cรณdigo TPS-Q402
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
.
Commercial Name
19-945 IVD Reagents/Assays, Immunoassay, Rapid, Tumor Marker, Prostate Specific Antigen
Registration Information
Analysis ID
43f17b74643e363d84b6829addeed809
Registration Date
July 06, 2022
Expiration Date
July 06, 2027
Product Use

FOR THE QUALITATIVE DETECTION OF PROSTATE-SPECIFIC ANTIGEN IN WHOLE BLOOD, SERUM OR PLASMA.

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