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Xpert®HCV Viral Load - ARCSA Registration 32a042cdac32b8545a58b97758f81d78

Access comprehensive regulatory information for Xpert®HCV Viral Load in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 32a042cdac32b8545a58b97758f81d78 and manufactured by CEPHEID AB. The device was registered on July 14, 2015.

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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III
32a042cdac32b8545a58b97758f81d78
Xpert®HCV Viral Load
ARCSA ID: 32a042cdac32b8545a58b97758f81d78
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
GeneXpert®
Commercial Name
IVD Reagents/Kits, Molecular Assay, Infection, Virus
Sterilization Method
MOLECULAR BIOLOGY BY PC
Registration Information
Analysis ID
32a042cdac32b8545a58b97758f81d78
Registration Date
July 14, 2015
Expiration Date
July 14, 2025
Creation Date
June 27, 2020
Product Use

FOR RAPID QUANTIFICATION OF HCV VIRUS RNA

Manufacturer
Country
SWEDEN
Address
RONTGENVÄGEN 5, SE-171 54 SOLNA, SWEDEN
Product Owner
Name
CEPHEID AB
Country
SWEDEN
Authorized Representative
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680