QUANTASETM NEONATAL PHENYLALANINE & TOTAL GALACTOSE SCREENING (BLOOD SPOT STANDARDS & CONTROLS) - COFEPRIS Registration 1229R2018 SSA
Access comprehensive regulatory information for QUANTASETM NEONATAL PHENYLALANINE & TOTAL GALACTOSE SCREENING (BLOOD SPOT STANDARDS & CONTROLS) (QUANTASETM NEONATAL PHENYLALANINE & TOTAL GALACTOSE SCREENING (BLOOD SPOT STANDARDS & CONTROLS)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1229R2018 SSA and manufactured by BIO-RAD, S.A.. The device was registered on May 30, 2018.
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.
LOS ESTÁNDARES SE EMPLEAN PARA REALIZAR LA CALIBRACIÓN DEL ENSAYO YA QUE CADA ESTÁNDAR TIENE UNA CONCENTRACIÓN DIFERENTE DEL ANALITO A EVALUAR. LOS CONTROLES MANCHA DE SANGRE SE EMPLEAN COMO REFERENCIA DE DESEMPEÑO E IMITAN LAS CONDICIONES DE UNA MUESTRA
THE STANDARDS ARE USED TO PERFORM THE CALIBRATION OF THE TEST SINCE EACH STANDARD HAS A DIFFERENT CONCENTRATION OF THE ANALYTE TO BE EVALUATED. BLOOD STAIN CONTROLS ARE USED AS A PERFORMANCE BENCHMARK AND MIMIC THE CONDITIONS OF A SAMPLE