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Abbott Ireland Diagnostics Division

Manufacturer • Ireland · 80 devices on the TGA ARTG · 4 device classes · Feb 15, 2011 – Oct 01, 2024

80
Total Devices
4
Device Classes
2011
Earliest
2024
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Clinical chemistry therapeutic drug monitoring IVDs
ARTG 463246
Class IIbOct 01, 2024
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
Class IIbAug 11, 2022
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
ARTG 393812
Class IIbAug 11, 2022
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Multiple clinical chemistry constituent IVDs
Class IIaMar 24, 2022
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Clinical chemistry trace element IVDs
ARTG 386225
Class IIaMar 24, 2022
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Multiple clinical chemistry constituent IVDs
ARTG 386226
Class IIaMar 24, 2022
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Clinical chemistry trace element IVDs
Class IIaMar 24, 2022
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Alinity i HBsAg Next Qualitative Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Class IIISep 23, 2021
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Alinity i HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ARTG 375204
Class IIISep 23, 2021
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
Alinity i HBsAg Next Qualitative Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ARTG 375203
Class IIISep 23, 2021
Sponsor: Abbott Australasia Pty Ltd Diagnostic Division
View All 80 Devices →
Risk class distribution
Devices by risk class
Class I
2
2.5% of total
Class IIa
28
35.0% of total
Class IIb
21
26.3% of total
Class III
29
36.3% of total
About this profile

Explore comprehensive manufacturer profile for Abbott Ireland Diagnostics Division through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 80 medical devices registered with TGA ARTG across 4 device classes. This manufacturer is based in Ireland. Their registration history spans from Feb 15, 2011 to Oct 01, 2024.

This page provides detailed insights including recent device registrations, risk class distribution (Class III: 29, Class IIa: 28, Class IIb: 21, Class I: 2), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices.

Free Manufacturer ProfilePowered by Pure Global AI80 Devices4 Device Classes