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BECKMAN COULTER ARGENTINA S.A.

407 devices registered with ANMAT · 5 registration types · Jul 31, 2018 – Aug 13, 2024

407
Total Devices
5
Registration Types
2018
Earliest
2024
Latest
Recent registrations
Latest 20 ANMAT device registrations
1) Access Inhibin A (Reagent Pack); 2) Access Inhibin A (Calibrator); 3) Access Inhibin A (QC)
1109-467
Registration of products for IVD diagnostics - Group C and DAug 13, 2024
1) AQUIOS STEM Software Kit; 2) AQUIOS STEM Kit Reagents; 3) AQUIOS STEM CD34 Control Cells Kit
1109-495
Agile modification of product registration for IVD diagnostics - Group C and DMay 02, 2024
DxC 500 AU Clinical Chemistry Analyzer
1109-469
IVD Registration Group A and BMay 02, 2024
1) Access NT-proBNP (reagent pack); 2) Access NT-proBNP (calibrators)
1109-517
Registration of products for IVD diagnostics - Group C and DApr 29, 2024
IMMAGE Immunochemistry Systems MA Microalbumin Reagent
1109-351
IVD Modification Group A and BApr 26, 2024
1) Access C-Peptide 2) Access C-Peptide Calibrator
1109-426
IVD Modification Group A and BApr 16, 2024
CRP
1109-123
IVD Modification Group A and BFeb 05, 2024
Transferrin
1109-136
IVD Modification Group A and BJan 30, 2024
1) Access Total ßhCG (5th IS) (Reagent Pack); 2) Access Total ßhCG (5th IS) (Reagent Pack); 3) Access Total ßhCG (5th IS) (Calibrator)
1109-520
Registration of products for IVD diagnostics - Group C and DNov 23, 2023
1) Access DHEA-S: 2) Access DHEA-S Calibrators
1109-518
Registration of products for IVD diagnostics - Group C and DNov 23, 2023
LabPro V5.0
1109-503
Registration of products for IVD diagnostics - Group C and DNov 16, 2023
1) Access CK-MB; 2) Access CK-MB Calibrators
1109-510
Registration of products for IVD diagnostics - Group C and DNov 16, 2023
1) Access BNP; 2) Access BNP Calibrators; 3) Access BNP QC
1109-522
Registration of products for IVD diagnostics - Group C and DNov 16, 2023
Coulter Isoton II Diluent 20L
1109-465
IVD Registration Group A and BNov 15, 2023
1) Access Thyroglobulin Antibody II (Reagent Pack) 2) Access Thyroglobulin Antibody II (Calibrators)
1109-166
IVD Modification Group A and BNov 15, 2023
1) iQ Calibrator Pack 2) iQ Control/Focus Set 3) iChem VELOCITY CalCheck Kit 4.1) 800-7702 IRISpec CA/CB/CC Controls 4.2) 800-7211 IRISpec CA/CB/CC Controls 5) iQ Precision Kit
1109-241
IVD Modification Group A and BNov 09, 2023
iChem VELOCITY Urine Chemistry Strips
1109-248
IVD Modification Group A and BNov 07, 2023
1) iQ Lamina 2) Iris Diluent Pack 3) iChem VELOCITY Wash Solution 4) iQ Body Fluids Lysing Reagent 5) Iris System Cleanser Pack
1109-236
IVD Modification Group A and BOct 24, 2023
1) DxH 500 Hematology Instrument 2) DxH 500 Series Cleaner 3) DxH 500 Series Diluent 4) DxH 500 Series Controls 5) DxH 500 Series Calibrator 6) DxH 500 Series Lyse
1109-273
IVD Modification Group A and BOct 20, 2023
1) MBT Compass HT IVD; 2) MBT HT Subtyping IVD Module; 3) MBT HT Sepsityper IVD Module; 4) MBT HT Mycobacteria IVD Module; 5) MBT HT Filamentous Fungi IVD Module; 6) MBT HT STAR-BL IVD Module
1109-527
Registration of products for IVD diagnostics - Group C and DOct 10, 2023
View All 407 Devices →
Registration type distribution
Devices by registration type
IVD Modification Group A and B
262
64.4% of total
IVD Registration Group A and B
72
17.7% of total
Registration of products for IVD diagnostics - Group C and D
44
10.8% of total
Agile modification of product registration for IVD diagnostics - Group C and D
24
5.9% of total
Non-agile modification of products for IVD diagnostics - Group C and D
5
1.2% of total
About this profile

Explore comprehensive authorized company profile for BECKMAN COULTER ARGENTINA S.A. through Pure Global AI's free Argentina medical device database. This company manufactures 407 medical devices registered with ANMAT across 5 registration types. Their registration history spans from Jul 31, 2018 to Aug 13, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Modification Group A and B: 262, IVD Registration Group A and B: 72, Registration of products for IVD diagnostics - Group C and D: 44, 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 AI407 Devices5 Registration Types