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Alpha-Fetoprotein (eCLIA) - ARCSA Registration f240bdcb91f5fdef1d5ccb2c0dc216df

Access comprehensive regulatory information for Alpha-Fetoprotein (eCLIA) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID f240bdcb91f5fdef1d5ccb2c0dc216df and manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.. The device was registered on June 04, 2021.

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
f240bdcb91f5fdef1d5ccb2c0dc216df
Alpha-Fetoprotein (eCLIA)
ARCSA ID: f240bdcb91f5fdef1d5ccb2c0dc216df
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
LIFOTRONIC
Commercial Name
19-096 IVD Reagents/Kits, Immunoassay, Tumor Marker
Registration Information
Analysis ID
f240bdcb91f5fdef1d5ccb2c0dc216df
Registration Date
June 04, 2021
Expiration Date
June 04, 2026
Product Use

IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN SAMPLES OF SERUM OR HUMAN PLASMA, CLINICALLY USED MAINLY FOR THE DIAGNOSIS ASSISTED IN THE DETERMINATION OF THE EFFICACY AND THE OBSERVATION OF THE PROGNOSIS OF PRIMARY LIVER CANCER.

Manufacturer
City
SHENZHEN
Country
CHINA
Address
4TH FLOOR, BUILDING 15, 1008 SONGBAI ROAD, NANSHAN DISTRICT, SHENZHEN, 518055, CHINA
Product Owner
Name
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
JUAN PICALLO OE1-157 AND TINOCOCHA
Phone
22525424