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Xpert ® Bladder Cancer Detection - ARCSA Registration 92d1d6c1844052c420535bbc1d33b9e4

Access comprehensive regulatory information for Xpert ® Bladder Cancer Detection in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 92d1d6c1844052c420535bbc1d33b9e4 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.

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III
92d1d6c1844052c420535bbc1d33b9e4
Xpert ® Bladder Cancer Detection
ARCSA ID: 92d1d6c1844052c420535bbc1d33b9e4
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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
92d1d6c1844052c420535bbc1d33b9e4
Registration Date
October 05, 2022
Expiration Date
October 05, 2027
Creation Date
May 10, 2022
Product Use

IT IS A QUALITATIVE IN VITRO DIAGNOSTIC TEST DESIGNED TO DETECT THE PRESENCE OF BLADDER CANCER IN PATIENTS WITH HEMATURIA WHO ARE SUSPECTED OF HAVING BLADDER CANCER.

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