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6907c3babf73e11c543898703cd6ed81

Xpert®FLU

CEPHEID AB·III·Ecuador ARCSA·Registered March 03, 2017
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
XPERT
Commercial name
IVD Reagents/Kits, Molecular Assay, Infection, Viruses, Influenza A/B, RNA
Sterilization method
BIOLOGIA MOLECULAR PCR.
Registration information
Analysis ID
6907c3babf73e11c543898703cd6ed81
Registration date
March 03, 2017
Expiration date
March 03, 2027
Creation date
March 15, 2022
Manufacturer
Name
CEPHEID AB
Country
SWEDEN
Address
RONTGENVAGEN 5, SE-171 54, SOLNA SWEDEN
Product owner
Name
CEPHEID AB
Country
SWEDEN
Authorized representative
Name
HEALTH SYSTEMS ROCARSYSTEM S.A.
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680
Product use

FOR THE QUALITATIVE DETECTION AND IN VITRO DIFFERENTIATION OF RIBONUCLEIC ACID (RNA) OF INFLUENZA A, INFLUENZA B AND INFLUENZA 2009 H1N1 VIRUSES

About this record

Access comprehensive regulatory information for Xpert®FLU in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 6907c3babf73e11c543898703cd6ed81 and manufactured by CEPHEID AB. The device was registered on March 03, 2017.

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.