Abbott Ireland
SLIGO Sligo, IE
ABBOTT IRELAND appears in FDA device records in SLIGO Sligo, IE. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Abbott Ireland in 2025.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 2 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008344661 | 3008344661 | ABBOTT IRELAND | DIAGNOSTICS DIVISION, SLIGO - IE | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- CJYAzo Dye, Calcium
- QATBrain Trauma Assessment Test
- JISCalibrator, Primary
- JITCalibrator, Secondary
- PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- MLMEnzyme Immunoassay, Tracrolimus
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- GGJFluid, Diluting, White-Cell
- JHXFluorometric Method, Cpk Or Isoenzymes
- JFTFluorometric, Cortisol
- CFRHexokinase, Glucose
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects
- DDRMyoglobin, Antigen, Antiserum, Control
- JCCPh Buffer
- PRIProcalcitonin Assay
- GGKProducts, Red-Cell Lysing Products
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- SEIQualitative And Quantitative Hepatitis B Virus Antibody Assays
- KHQRadioassay, Triiodothyronine Uptake
- QKOReagent, Coronavirus Serological
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NRPSirolimus Test System
- GJHStain, Reticulocyte
- DHXSystem, Test, Carcinoembryonic Antigen
- DHASystem, Test, Human Chorionic Gonadotropin
- JZOSystem, Test, Thyroid Autoantibody
- MZATest, Equipment, Automated Bloodborne Pathogen
- LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1696-2023 | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 | Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU). | Class III | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain