SOLANA C. DIFFICILE ASSAY - COFEPRIS Registration 2182R2021 SSA
Access comprehensive regulatory information for SOLANA C. DIFFICILE ASSAY (SOLANA C. DIFFICILE ASSAY) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2182R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on December 16, 2021.
This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
SOLANA®C.DIFFICILEASSAYESUNAPRUEBADIAGNÓSTICAINVITROPARALADETECCIÓNCUALITATIVA DIRECTA DEL GEN QUECODIFICA LA TOXINA A DE CLOSTRIDIUMDIFFICILE(TCDA)ENMUESTRASDEHECESNOFORMADAS DE PACIENTES CON SOSPECHADE INFECCIÓN POR CLOSTRIDIUM DIFFICILE(CDI).ELENSAYOSOLANA®C.DIFFICILEESTÁPREVISTO COMO UNA AYUDA EN ELDIAGNÓSTICO DE CDI. LA PRUEBA ESTAPREVISTA PARA USO EXCLUSIVO CON ELSOLANA® INSTRUMENT.
SOLANA®C.DIFFICILEASSAY A DIAGNOSTIC TESTINVITROPARALDIRECT QUALITATIVE DETECTION OF THE GENE ENCODING CLOSTRIDIUM DIFFICILE TOXIN A (CTDA) IN STOOL SAMPLES FORMED FROM PATIENTS SUSPECTED OF CLOSTRIDIUM DIFFICILE INFECTION (CDI). THE SOLANA®C.DIFFICILE ASSAY IS INTENDED AS AN AID IN THE DIAGNOSIS OF CD. THE TEST IS INTENDED FOR EXCLUSIVE USE WITH ELSOLANA® INSTRUMENT.