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T153-402 CA15-3 Rapid Cassette Test (Whole Blood/Serum/Plasma) - ARCSA Registration 9f58b8554139d0b284432f4f76a14e10

Access comprehensive regulatory information for T153-402 CA15-3 Rapid Cassette Test (Whole Blood/Serum/Plasma) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 9f58b8554139d0b284432f4f76a14e10 and manufactured by HANGZHOU ALLTEST BIOTECH CO, LTD. The device was registered on November 22, 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
III
9f58b8554139d0b284432f4f76a14e10
T153-402 CA15-3 Rapid Cassette Test (Whole Blood/Serum/Plasma)
ARCSA ID: 9f58b8554139d0b284432f4f76a14e10
Local name: T153-402 Prueba Rápida de CA15-3 en Casete (Sangre Total / Suero / Plasma)
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
ALLTEST
Commercial Name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration Information
Analysis ID
9f58b8554139d0b284432f4f76a14e10
Registration Date
November 22, 2023
Expiration Date
November 22, 2028
Product Use

RAPID TEST FOR THE QUALITATIVE DETECTION OF CA 15-3 (ANTIGEN 15-3 CARCINOMA) IN HUMAN WHOLE BLOOD, SERUM OR PLASMA - IN VITRO DIAGNOSTICS

Manufacturer
City
HANGZHOU
Country
CHINA
Address
#550 TECHNOLOGICAL DEVELOPMENT AREA, HANGZHOU, 310018 ZHEJIANG P. R. CHINA
Product Owner
Name
HANGZHOU ALLTEST BIOTECH CO, LTD
Country
CHINA
Authorized Representative
Address
AV DE LOS SHYRIS NUMBER: N34-40 AND REPUBLICA DEL SALVADOR
Phone
26009479