Pure Global

Xpert®HCV VL Fingerstick - ARCSA Registration 4482e6297d8e15eab1c77d1179582763

Access comprehensive regulatory information for Xpert®HCV VL Fingerstick in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 4482e6297d8e15eab1c77d1179582763 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.

Free Database
Powered by Pure Global AI
ARCSA Official Data
III
4482e6297d8e15eab1c77d1179582763
Xpert®HCV VL Fingerstick
ARCSA ID: 4482e6297d8e15eab1c77d1179582763
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

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
4482e6297d8e15eab1c77d1179582763
Registration Date
July 14, 2015
Expiration Date
July 14, 2025
Creation Date
June 27, 2020
Product Use

FOR THE DETECTION AND QUANTIFICATION OF HEPATITIS C VIRUS (HCV) 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