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eCL8000 Automated ECL Immunoassay Analyzer - ARCSA Registration 0271e701be2ddac8053430f9b8407776

Access comprehensive regulatory information for eCL8000 Automated ECL Immunoassay Analyzer in the Ecuador medical device market through Pure Global AI's free database. This I medical device is registered under ARCSA ID 0271e701be2ddac8053430f9b8407776 and manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.. The device was registered on April 01, 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
I
0271e701be2ddac8053430f9b8407776
eCL8000 Automated ECL Immunoassay Analyzer
ARCSA ID: 0271e701be2ddac8053430f9b8407776
Local name: eCL8000 Analizador de Inmunoensayo ECL Automatizado
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Device Classification
Risk Class
I
Product Type
In Vitro Diagnostic
Brand Name
Lifotronic
Commercial Name
17-916 Analyzers, Laboratory, Immunoassay, Chemoluminescence
Sterilization Method
INMUNOANALISIS
Registration Information
Analysis ID
0271e701be2ddac8053430f9b8407776
Registration Date
April 01, 2022
Expiration Date
April 01, 2027
Creation Date
January 04, 2022
Product Use

THE PRODUCT ADOPTS THE DIRECT ELECTROCHEMILUMINESCENCE METHOD BASED ON RUTHENIUM TERPYRIDINE (TRIS 2 BIPYRIDYL RUTHENIUM) AND IS USED TOGETHER WITH CORRESPONDING DETECTION REAGENTS. IT IS USED CLINICALLY FOR THE QUALITATIVE OR QUANTITATIVE DETECTION OF ANALYTES CONTAINED IN HUMAN SERUM AND PLASMA SAMPLES, INCLUDING HORMONAL ITEMS.

Manufacturer
City
SHENZHEN
Country
CHINA
Address
UNIT A, 4TH FLOOR, BUILDING 15,YIJING ESTATE, NO.1008 SONGBAI ROAD, NANSHAN DISTRICT, SHENZHEN CITY, GUANGDONG PROVINCE, 518055
Product Owner
Name
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
KENNEDY NORTE. MIGUEL H ALCIVAR. AV NUEVE EDIFICIO BLUE CENTER 3ER PISO OF 25
Phone
42384590