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384bfe264cb7c710ecf84eb5f76a0da1

Xpert Xpress Flu/RSV

CEPHEID·III·Ecuador ARCSA·Registered October 15, 2020
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
GeneXpert
Commercial name
19-242.- Reagents/Kits for IVD Assays, Molecular Assay, Infection, Viruses
Sterilization method
METHODOLOGY: MOLECULAR BIOLOGY
Registration information
Analysis ID
384bfe264cb7c710ecf84eb5f76a0da1
Registration date
October 15, 2020
Expiration date
October 15, 2025
Creation date
October 15, 2020
Manufacturer
Name
CEPHEID
City
SUNNYVALE, CA
Country
UNITED STATES
Address
904 CARIBBEAN DRIVE SUNNYVALE, CA USA 94089
Product owner
Name
CEPHEID
Country
UNITED STATES
Authorized representative
Name
HEALTH SYSTEMS ROCARSYSTEM S.A.
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680
Product use

INTENDED FOR QUALITATIVE DETECTION AND IN VITRO DIFFERENTIATION OF RNA FROM INFLUENZA A, INFLUENZA B AND INFLUENZA B VIRUSES RESPIRATORY SYNCYTIAL (RSV).

About this record

Access comprehensive regulatory information for Xpert Xpress Flu/RSV in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 384bfe264cb7c710ecf84eb5f76a0da1 and manufactured by CEPHEID. The device was registered on October 15, 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.