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93ed5eed55087dab2289c2eceb7d0574

Xpert® C. DIFFICULT BT

Local name: Xpert® C. DIFFICILE BT
CEPHEID AB·III·Ecuador ARCSA·Registered May 19, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
XPERT
Commercial name
21-789.- Reagents/Kits for IVD Tests, Serology, Bacteria, Clostridium difficile
Sterilization method
METHODOLOGY: MOLECULAR DIAGNOSIS
Registration information
Analysis ID
93ed5eed55087dab2289c2eceb7d0574
Registration date
May 19, 2022
Expiration date
May 19, 2027
Creation date
May 19, 2022
Manufacturer
Name
CEPHEID AB
City
LONDON
Country
SWEDEN
Address
RONTGENVÄGEN 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

IT IS A TEST OF IN VITRO DIAGNOSIS FOR RAPID DETECTION OF C. DIFFICILE TCDB (TOXIN B GENE), CDT (BINARY TOXIN GENE) AND DELETION OF A NUCLEOTIDE AT POSITION 117 OF THE TCDC GENE FROM REPORTED STOOL SAMPLES (LIQUID OR SOFT) OBTAINED FROM PATIENTS WITH SUSPECTED CLOSTRIDIUM DIFFICILE INFECTION (ICD)

About this record

Access comprehensive regulatory information for Xpert® C. DIFFICULT BT in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 93ed5eed55087dab2289c2eceb7d0574 and manufactured by CEPHEID AB. The device was registered on May 19, 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.