Pure Global
Argentina flagAuthorized company profile

ROCHE S.A. PRODUCTS

PRODUCTOS ROCHE S.A.

660 devices registered with ANMAT · 11 registration types · Apr 04, 2018 – Aug 14, 2024

660
Total Devices
11
Registration Types
2018
Earliest
2024
Latest
Recent registrations
Latest 20 ANMAT device registrations
Immunological test for the quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma.
Test inmunológico para la determinación cuantitativa de la gonadotropina coriónica humana (hCG) en suero y plasma humanos.
740-8544
Non-agile modification of products for IVD diagnostics - Group C and DAug 14, 2024
Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) in human serum and plasma.
Inmunoensayo de electroquimioluminiscencia ”ECLIA” destinado a la detección cuantitativa del antígeno prostático específico total (tPSA) en suero y plasma humanos.
740-738
Non-agile modification of products for IVD diagnostics - Group C and DAug 09, 2024
Electrochemiluminescence immunoassay "ECLIA" for the quantitative determination of a1-fetoprotein in human serum and plasma.
Inmunoensayo de Electroquimioluminiscencia "ECLIA" para la determinación cuantitativa de la a1-fetoproteína en suero y plasma humanos.
740-8563
Agile modification of product registration for IVD diagnostics - Group C and DAug 08, 2024
An algorithm that can be used in conjunction with other diagnostic methods to detect hepatocellular carcinoma.
Algoritmo que puede utilizarse junto con otros métodos de diagnóstico para detectar el carcinoma hepatocelular.
740-833
Non-agile modification of products for IVD diagnostics - Group C and DAug 08, 2024
System for Continuous Subcutaneous Insulin Infusion.
Sistema para la Infusión Subcutánea Continua de Insulina.
740-886
Registration Class III-IVAug 05, 2024
1- cobas pro Transport Belt (2 AU, 2 ISE) 2- cobas pro Transport Belt (3 AU, 2 ISE) 3- cobas pro Transport Belt (4 AU, 2 ISE) 4- cobas pro SSU 5- cobas pro SB 6- cobas pro transport line 7- cobas pro SBL c 503 8- cobas pro SBL e 801 9- cobas c 703 analytical unit 10- cobas ISE neo 1800 analytical unit 11- cobas ISE neo 900 analytical unit 12- cobas pro SBL c 703 13- Reaction Cell for c 703 14- Alarm Tower Kit 15- cobas c 503 decoupling kit 16- ISE Internal Standard Gen.2 conc. 17- 3000m Liq.Fl.Path Mod.kit e801
740-784
IVD Modification Group A and BJul 30, 2024
Accu-Chek Performa Glucose Monitoring System
Sistema de monitoreo de glucosa Accu-Chek Performa
740-880
Registration of products for IVD diagnostics - Group C and DJul 24, 2024
1- Cobas SARS-COV-2 – 192T 2- Cobas SARS-COV-2 – 480T 3-2 Control Kit 4- Cobas SARS-COV-2 Qualitative 192T 5- Cobas SARS-COV-2 Qualitative 480T 6- Coach SARS-COV-2 Control Qualitative Kit
1- cobas SARS-COV-2 – 192T 2- cobas SARS-COV-2 – 480T 3- cobas SARS-COV-2 Control Kit 4- cobas SARS-COV-2 Qualitative 192T 5- cobas SARS-COV-2 Qualitative 480T 6- cobas SARS-COV-2 Control Qualitative Kit
740-800
IVD Modification Group A and BJul 17, 2024
1- cobas SARS-COV-2 Nucleic acid test for use on the cobas Liat System 2- cobas SARS-COV-2 Quality Control Kit for use on the cobas Liat System
740-813
IVD Modification Group A and BJul 17, 2024
Elecsys HTLV-I/II
740-590
Agile modification of product registration for IVD diagnostics - Group C and DJul 17, 2024
1) CC 25mM 2) Owren B 3) Day Clean 4) CleanSol 5) Imid Buff 6) Kaolin
740-453
IVD Modification Group A and BJul 16, 2024
Immunoassays for the quantitative determination of CA 72-4 in human serum and plasma.
Inmunoensayos para la determinación cuantitativa del CA 72-4 en suero y plasma humanos.
740-3905
Agile modification of product registration for IVD diagnostics - Group C and DJul 15, 2024
Immunoassay for the qualitative determination of hepatitis B surface antigen (HBsAg).
Inmunoensayo para la determinación cualitativa del antígeno de superficie de la hepatitis B (HBsAg).
740-588
Non-agile modification of products for IVD diagnostics - Group C and DJul 15, 2024
In vitro immunoassay for the quantitative determination of CA 15-3 antigen in human serum and plasma.
Inmunoensayo in vitro para la determinación cuantitativa del antígeno CA 15-3 en suero y plasma humanos .
740-554
Non-agile modification of products for IVD diagnostics - Group C and DJul 15, 2024
ACCU-CHEK Active Glucose Monitoring System
Sistema de monitoreo de glucosa ACCU-CHEK Active
740-879
Registration of products for IVD diagnostics - Group C and DJul 05, 2024
cobas e 402 analytical unit.
740-783
IVD Modification Group A and BJul 01, 2024
1- Elecsys PTH 2- CalSet PTH 3- Elecsys PTH (1-84) 4- CalSet II PTH
740-851
IVD Modification Group A and BJun 25, 2024
Assays for different coagulation tests on cobas t 511/711 and cobas t 411 analyzers
Ensayos destinados a diferentes pruebas de coagulación en los analizaodres cobas t 511/711 y cobas t 411
740-859
Non-agile modification of products for IVD diagnostics - Group C and DJun 13, 2024
ACCU-CHECK Guide Glucose Monitoring System
Sistema de monitoreo de glucosa ACCU-CHECK Guide
740-881
Registration of products for IVD diagnostics - Group C and DJun 07, 2024
1- AssayTip/AssayCup 2- AssayTip 3- AssayTip/AssayCup Tray 4- AssayCup
740-727
IVD Modification Group A and BJun 06, 2024
View All 660 Devices →
Registration type distribution
Devices by registration type
IVD Modification Group A and B
333
50.5% of total
IVD Registration Group A and B
156
23.6% of total
Non-agile modification of products for IVD diagnostics - Group C and D
65
9.8% of total
Agile modification of product registration for IVD diagnostics - Group C and D
57
8.6% of total
Registration of products for IVD diagnostics - Group C and D
35
5.3% of total
Class I-II Registration
7
1.1% of total
Class I-II Registration Modification
3
0.5% of total
Class I-II Registration Revalidation
1
0.2% of total
Revalidation + Modification of Class I-II Registration
1
0.2% of total
Revalidation of Registration I-II-III-IV
1
0.2% of total
Registration Class III-IV
1
0.2% of total
About this profile

Explore comprehensive authorized company profile for ROCHE S.A. PRODUCTS through Pure Global AI's free Argentina medical device database. This company manufactures 660 medical devices registered with ANMAT across 11 registration types. Their registration history spans from Apr 04, 2018 to Aug 14, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Registration Group A and B: 156, IVD Modification Group A and B: 333, Agile modification of product registration for IVD diagnostics - Group C and D: 57, and more), and complete regulatory information from the official Argentina ANMAT (National Administration of Drugs, Foods and Medical Technology) medical device database with bilingual Spanish/English support. Pure Global AI offers free access to Argentina's complete medical device registry.

Free Authorized Company ProfilePowered by Pure Global AI660 Devices11 Registration Types