46e8c549e6c9f06944cc74557e68ed25

Xpert Xpress CoV-2/FLU/RSV pus

CEPHEID·III·Ecuador ARCSA·Registered April 20, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
Xpert
Commercial name
19-242.- Reagents/Kits for IVD Assays, Molecular Assay, Infection, Viruses
Sterilization method
METHODOLOGY: MOLECULAR BIOLOGY
Registration information
Analysis ID
46e8c549e6c9f06944cc74557e68ed25
Registration date
April 20, 2022
Expiration date
April 20, 2027
Creation date
April 20, 2022
Manufacturer
City
SUNNYVALE, CA
Country
UNITED STATES
Address
904, CARIBBEAN DRIVE -SUNNYVALE, CA 94089 - USA
Product owner
Name
CEPHEID
Country
UNITED STATES
Authorized representative
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680
Product use

INDICATED FOR THE SIMULTANEOUS QUALITATIVE DETECTION AND DIFFERENTIATION IN VITRO OF THE RNA OF SARS-COV-2 VIRUSES, INFLUENZA A, INFLUENZA B AND RESPIRATORY SYNCYTIAL VIRUS (RSV) IN NASOPHARYNGEAL SWAB OR ANTERIOR NASAL SWAB SAMPLES COLLECTED FROM PEOPLE WITH SIGNS OR SYMPTOMS OF RESPIRATORY INFECTION OF VIRAL ORIGIN.

About this record

Access comprehensive regulatory information for Xpert Xpress CoV-2/FLU/RSV pus in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 46e8c549e6c9f06944cc74557e68ed25 and manufactured by CEPHEID. The device was registered on April 20, 2022.

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.