Xpert® Xpress SARS-CoV-2 - ARCSA Registration 13c031c4132f35edff9ec1eea1ce44fe
Access comprehensive regulatory information for Xpert® Xpress SARS-CoV-2 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 13c031c4132f35edff9ec1eea1ce44fe and manufactured by CEPHEID. The device was registered on April 02, 2020.
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
13c031c4132f35edff9ec1eea1ce44fe
Xpert® Xpress SARS-CoV-2
ARCSA ID: 13c031c4132f35edff9ec1eea1ce44fe
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
XPERT
Commercial Name
IVD Reagents/Kits, Molecular Assay, Infection, Virus
Sterilization Method
METHODOLOGY: MOLECULAR DIAGNOSIS
Registration Information
Analysis ID
13c031c4132f35edff9ec1eea1ce44fe
Registration Date
April 02, 2020
Expiration Date
April 02, 2025
Creation Date
June 18, 2021
Product Use
FOR THE QUALITATIVE DETECTION OF SARS-COV-2 NUCLEIC ACID IN PHARYNGEAL SWAB SAMPLES
Manufacturer
Product Owner
Name
CEPHEID
Country
UNITED STATES
Authorized Representative
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680