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Xpert®HIV-1 Qual - ARCSA Registration bf72d3e6556857f1b19151b5e4e0356f

Access comprehensive regulatory information for Xpert®HIV-1 Qual in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID bf72d3e6556857f1b19151b5e4e0356f 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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ARCSA Official Data
III
bf72d3e6556857f1b19151b5e4e0356f
Xpert®HIV-1 Qual
ARCSA ID: bf72d3e6556857f1b19151b5e4e0356f
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Pricing
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
bf72d3e6556857f1b19151b5e4e0356f
Registration Date
July 14, 2015
Expiration Date
July 14, 2025
Creation Date
June 27, 2020
Product Use

TO DETECT HIV VIRUS TOTAL NUCLEIC ACIDS

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