Xpert® C. DIFFICULT BT - ARCSA Registration 93ed5eed55087dab2289c2eceb7d0574
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.
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)