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dbf24e5a6483c1534bb08dcee63f34a1

Xpert ® Breast Cancer STRAT4

CEPHEID·III·Ecuador ARCSA·Registered October 05, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
Xpert
Commercial name
26-998.- Reagents/Kits for IVD Assays, Molecular Assay, Gene Expression
Sterilization method
METHODOLOGY: MOLECULAR DIAGNOSIS
Registration information
Analysis ID
dbf24e5a6483c1534bb08dcee63f34a1
Registration date
October 05, 2022
Expiration date
October 05, 2027
Creation date
May 10, 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 SEMI-QUANTITATIVE ASSAY BASED ON POLYMERASE CHAIN REACTION WITH QUALITATIVE CUT-OFF VALUES FOR ESTROGEN RECEPTOR MRNA (ESR1), PROGESTERONE RECEPTOR (PGR), HUMAN EPIDERMAL GROWTH FACTOR 2 (ERBB2/HER2) AND PROLIFERATION MARKER KI-67 (MKI67) ISOLATED FROM TISSUE OF INVASIVE BREAST CANCER FIXED IN FORMALIN AND INCLUDED IN PARAFFIN (FFPE).

About this record

Access comprehensive regulatory information for Xpert ® Breast Cancer STRAT4 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID dbf24e5a6483c1534bb08dcee63f34a1 and manufactured by CEPHEID. The device was registered on October 05, 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.