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02fc1b68207035d0836c9c30e92e4dfc

Xpert Xpress CoV-2 plus

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
02fc1b68207035d0836c9c30e92e4dfc
Registration date
April 20, 2022
Expiration date
April 20, 2027
Creation date
November 23, 2022
Manufacturer
Name
CEPHEID
City
SUNNYVALE, CA
Country
UNITED STATES
Address
904, CARIBBEAN DRIVE -SUNNYVALE, CA 94089 - USA
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

IT IS A REAL-TIME RT-PCR TEST FOR THE QUALITATIVE DETECTION OF SARS-COV-2 NUCLEIC ACIDS IN NASOPHARYNGEAL SWAB OR NASAL SWAB SAMPLES.

About this record

Access comprehensive regulatory information for Xpert Xpress CoV-2 plus in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 02fc1b68207035d0836c9c30e92e4dfc 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.