FASTPACK® HCG - COFEPRIS Registration 176R2019 SSA
Access comprehensive regulatory information for FASTPACK® HCG (FASTPACK® HCG) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 176R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on February 01, 2019.
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.
LA PRUEBA FASTPACK® HCG ESTÁ DISEÑADA PARA SU USO CON EL SISTEMA FASTPACK® Y ESTÁ INDICADA PARA LA DETECCIÓN TEMPRANA DEL EMBARAZO. ES UN INMUNOENSAYO PARA LA DETERMINACIÓN CUANTITATIVA IN-VITRO DE HORMONA GONADOTROPINA CORIÓNICA (HCG) EN EL SUERO HUMANO
THE FASTPACK HCG TEST IS DESIGNED FOR USE WITH THE FASTPACK®® SYSTEM AND IS INDICATED FOR THE EARLY DETECTION OF PREGNANCY. IT IS AN IMMUNOASSAY FOR THE IN-VITRO QUANTITATIVE DETERMINATION OF CHORIONIC GONADOTROPIN HORMONE (HCG) IN HUMAN SERUM