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Real-Time PCR Assay for the Detection of Spinal Muscular Atrophy (SMA) Mutation from Dried Blood Spots of Neonates

Ensayo por PCR en Tiempo Real para la detección de la mutación de la atrofia muscular espinal (AME) a partir de manchas de sangre seca de neonatos

Argentina Medical Device Registration · ZenTech · BIODIAGNOSTICO S.A. · Registered June 06, 2024

Registration of products for IVD diagnostics - Group C and D
Device classification
Registration Type
Registration of products for IVD diagnostics - Group C and D
Registro De Productos Para Diagnóstico IVD - Grupo C Y D
Product Code
1201-420
Brand Name
ZenTech
Product Name
Real-Time PCR Assay for the Detection of Spinal Muscular Atrophy (SMA) Mutation from Dried Blood Spots of Neonates
Ensayo por PCR en Tiempo Real para la detección de la mutación de la atrofia muscular espinal (AME) a partir de manchas de sangre seca de neonatos
Registration information
Registration Date
June 06, 2024
Database ID
cmhayu7b30lr3ekuzp6zahtzr
Authorized representative
Documents
Product information

1)Targeted qPCR SMA (Código K-LT-480) 2)Targeted qPCR SMA FLEX (Código K-MF-480)

About this record

Access comprehensive regulatory information for Real-Time PCR Assay for the Detection of Spinal Muscular Atrophy (SMA) Mutation from Dried Blood Spots of Neonates in the Argentina medical device market through Pure Global AI's free database. This Registration of products for IVD diagnostics - Group C and D medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on June 06, 2024.

This page provides complete registration details including product code (1201-420), brand name (ZenTech), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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