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iStar-Troponin-I - ARCSA Registration 74122aa3ad08613ce3d1f57d56aa3226

Access comprehensive regulatory information for iStar-Troponin-I in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 74122aa3ad08613ce3d1f57d56aa3226 and manufactured by SHENZHEN YHLO BIOTECH CO., LTD.. The device was registered on April 30, 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
74122aa3ad08613ce3d1f57d56aa3226
iStar-Troponin-I
ARCSA ID: 74122aa3ad08613ce3d1f57d56aa3226
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
DRAWRAY
Commercial Name
19-704 IVD Reagents/Assay Kits, Immunoassay, Cardiac Marker, Protein
Registration Information
Analysis ID
74122aa3ad08613ce3d1f57d56aa3226
Registration Date
April 30, 2023
Expiration Date
April 30, 2028
Product Use

QUANTITATIVE DETERMINATION OF CARDIAC TROPONIN-I (TNL) IN HUMAN SERUM AND PLASMA USING THE ISTAR IMMUNOASSAY ANALYZER.

Manufacturer
City
SHENZHEN
Country
CHINA
Address
BUILDING 1, YHLO BIOPARK, BAOLONG 2ND ROAD, BAOLONG SUBDISTRICT, LONGGANG DISTRICT 518116 SHENZHEN, PLEOPLE'S REPUBLIC OF CHINA
Product Owner
Name
SHENZHEN DRAWRAY BIOTECH CO., LTD
Country
CHINA
Authorized Representative
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600