NEPHSTAR HBA1C KIT AND HBA1CCONTROL. - COFEPRIS Registration 1314R2021 SSA
Access comprehensive regulatory information for NEPHSTAR HBA1C KIT AND HBA1CCONTROL. (NEPHSTAR HBA1C KIT AND HBA1CCONTROL.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1314R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on January 09, 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.
EL NEPHSTAR HBA1C KIT AND HBA1CCONTROL,SEUTILIZAENELANALIZADORDEPROTEÍNAS NEPHSTAR PARA LADETERMINACIÓN CUANTITATIVA DELPORCENTAJEDEHEMOGLOBINAA1C(HBA1C)HUMANASOBREELTOTALDEHEMOGLOBINAEN SANGRE COMO AYUDA EN ELDIAGNÓSTICODELADIABETESMELLITUS. ELCONTROL HBA1C ESTÁN PREVISTO PARAUTILIZARSEALCALIBRARELENSAYOHBA1CDEL ANALIZADOR DE PROTEÍNASESPECÍFICAS GOLDSITE. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVO EN LABORATORIOS CLÍNICOS O
THE NEPHSTAR HBA1C KIT AND HBA1CCONTROL IS USED IN THE NEPHSTAR PROTEIN ANALYZER FOR THE QUANTITATIVE DETERMINATION OF THE PERCENTAGE OF HUMAN HEMOGLOBINAA1C(HBA1C) OVER TOTAL HEMOGLOBIN IN THE BLOOD AS AN AID IN THE DIAGNOSIS OF DIABETES MELLITUS. THE HBA1C CONTROL IS INTENDED TO BE USED TO CALIBRATE THE GOLDSITE-SPECIFIC PROTEIN ANALYZERHBA1C ASSAY. DIAGNOSTIC AGENTFORUSEINVITRO. FOR USE IN CLINICAL LABORATORIES ONLY, OR