1252-221Uromonitor® is a system designed to detect and monitor non-invasive muscle bladder carcinoma by detecting hotspot mutations in the TERT, FGFR3 and KRAS genes by Real-Time PCR from DNA extracted from exfoliated cells present in human urine.
Argentina Medical Device Registration · Uromonitor® · TECNOLAB S.A. · Registered July 17, 2024
Agile modification of product registration for IVD diagnostics - Group C and D- Registration Type
- Agile modification of product registration for IVD diagnostics - Group C and D
- Modificación Ágil De Registro De Productos Para Diagnóstico IVD - Grupo C Y D
- Product Code
- 1252-221
- Brand Name
- Uromonitor®
- Product Name
- Uromonitor® is a system designed to detect and monitor non-invasive muscle bladder carcinoma by detecting hotspot mutations in the TERT, FGFR3 and KRAS genes by Real-Time PCR from DNA extracted from exfoliated cells present in human urine.
- Uromonitor® es un sistema diseñado para detectar y controlar el carcinoma de vejiga músculo no invasivo mediante la detección de mutaciones de puntos críticos en los genes TERT, FGFR3 y KRAS por PCR en Tiempo Real desde el ADN extraído de células exfoliadas presentes en la orina humana.
- Registration Date
- July 17, 2024
- Database ID
- cmhayu5bc0k8eekuz2tzmnv58
- Name
- TECNOLAB S.A.
Access comprehensive regulatory information for Uromonitor® is a system designed to detect and monitor non-invasive muscle bladder carcinoma by detecting hotspot mutations in the TERT, FGFR3 and KRAS genes by Real-Time PCR from DNA extracted from exfoliated cells present in human urine. in the Argentina medical device market through Pure Global AI's free database. This Agile modification of product registration 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 July 17, 2024.
This page provides complete registration details including product code (1252-221), brand name (Uromonitor®), 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.