Argentina flag1201-434

1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer

Argentina Medical Device Registration · 1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer · BIODIAGNOSTICO S.A. · Registered July 17, 2024

IVD Registration Group A and B
Device classification
Registration Type
IVD Registration Group A and B
Registro IVD Grupo A y B
Product Code
1201-434
Brand Name
1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer
Product Name
1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer
Registration information
Registration Date
July 17, 2024
Database ID
cmhaytq49073cekuzvcmhgutk
Authorized representative
Documents
Product information

1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer

About this record

Access comprehensive regulatory information for 1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer in the Argentina medical device market through Pure Global AI's free database. This IVD Registration Group A and B 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 (1201-434), brand name (1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer), 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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