Xpert®HBV Viral Load - ARCSA Registration 55056131a0b947df4585291327eab8c5
Access comprehensive regulatory information for Xpert®HBV Viral Load in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 55056131a0b947df4585291327eab8c5 and manufactured by CEPHEID AB. The device was registered on May 10, 2019.
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
55056131a0b947df4585291327eab8c5
Xpert®HBV Viral Load
ARCSA ID: 55056131a0b947df4585291327eab8c5
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Xpert
Commercial Name
22-287.- Reagents/Kits for IVD Assays, Molecular Assay, Infection, Virus, Hepatitis B, DNA
Sterilization Method
METHODOLOGY: MOLECULAR BIOLOGY
Registration Information
Analysis ID
55056131a0b947df4585291327eab8c5
Registration Date
May 10, 2019
Expiration Date
May 10, 2024
Creation Date
October 16, 2020
Product Use
FOR QUANTIFICATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA
Manufacturer
Product Owner
Name
CEPHEID AB
Country
SWEDEN
Authorized Representative
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680