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Data / Medical devices / Ireland / Abbott Ireland

Abbott Ireland: FDA-registered device maker in Sligo, Ireland, 15 510(k) clearances and 6 PMA approvals

Abbott Ireland is registered with the FDA (registration 3008344661) in Sligo, Ireland. It lists 33 device types. The FDA files 15 510(k) clearances and 6 PMA approvals under its listings, the newest dated June 20, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Abbott Ireland
FDA registration number
3008344661
Address
Diagnostics Division Finisklin Business Park, Sligo, Ireland, -
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 13, 1977
Registered through
2027
Brand names listed
ACE Calibrator (LN 06U8201), ACE Calibrator (LN 06U8601), ACE Control (LN 06U8210), ACE Control (LN 06U8610), ARCHITECT AFP Calibrators (LN 3P36-01), ARCHITECT AFP Controls (LN 3P36-10), ARCHITECT AFP Reagent Kit (LN 3P36-25, 3P36-35), ARCHITECT AUSAB Calibrators (LN 1L82-02, 1L82-03) and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufactureraccessdata.fda.gov
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionPTF2Repackager or relabeleraccessdata.fda.gov
Brain Trauma Assessment TestQAT2Manufactureraccessdata.fda.gov
Calibrator, PrimaryJIS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensPMT2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, TracrolimusMLM2Specification developeraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificLGC2Specification developeraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Manufactureraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2MYF2Specification developeraccessdata.fda.gov
Fluid, Diluting, White-CellGGJ1Manufactureraccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Repackager or relabeleraccessdata.fda.gov
Fluorometric, CortisolJFT2Repackager or relabeleraccessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube DefectsLOK3Manufactureraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Repackager or relabeleraccessdata.fda.gov
Ph BufferJCC1Manufactureraccessdata.fda.gov
Procalcitonin AssayPRI2Repackager or relabeleraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Manufactureraccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Manufactureraccessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody AssaysSEI2Manufactureraccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Repackager or relabeleraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONManufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sirolimus Test SystemNRP2Specification developeraccessdata.fda.gov
Stain, ReticulocyteGJH1Manufactureraccessdata.fda.gov
System, Test, Carcinoembryonic AntigenDHX2Manufactureraccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Manufactureraccessdata.fda.gov
System, Test, Thyroid AutoantibodyJZO2Repackager or relabeleraccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANManufactureraccessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2Manufactureraccessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsMTG3Manufactureraccessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerMTF3Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 20, 2025K243168Alinity i Rubella IgGLFXSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 12, 2025K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYFSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
September 29, 2023K232669TBIQATSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
March 2, 2023K223602Traumatic brain injury (TBI) testQATSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 27, 2022K220949Architect CMV IgGLFZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 23, 2017K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHASubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 1, 2017K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsPRISubstantially EquivalentFisher Diagnosticsaccessdata.fda.gov
September 28, 2007K070822ARCHITECT SIROLIMUS ASSAYNRPSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
August 1, 2007K070820ARCHITECT TACROLIMUS: MODEL 1L77MLMSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
September 22, 2006K062204ARCHITECT CORTISOL ASSAYJFTSubstantially EquivalentSeradyn, Inc.accessdata.fda.gov
July 18, 2006K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSJZOSubstantially EquivalentFisher Diagnosticsaccessdata.fda.gov
May 10, 2006K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMJZOSubstantially EquivalentFisher Diagnosticsaccessdata.fda.gov
January 24, 2005K042924ARCHITECT STAT MYO IMMUNOASSAYDDRSubstantially EquivalentFisher Diagnosticsaccessdata.fda.gov
July 21, 2004K041596ARCHITECT STAT CK-MB IMMUNOASSAYJHXSubstantially EquivalentFisher Diagnosticsaccessdata.fda.gov
May 11, 1999K990774ABBOTT ARCHITECT CEADHXSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 10, 2022P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitLOM13April 3, 2025accessdata.fda.gov
November 28, 2012P120008ABBOTT ARCHITECT AFP ASSAYLOK32May 11, 2026accessdata.fda.gov
April 12, 2012P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLSLOM51April 3, 2025accessdata.fda.gov
June 1, 2006P050051ABBOTT ARCHITECT AUSABSEI60April 3, 2025accessdata.fda.gov
February 5, 2004P980007AXSYM FREE PSAMTG55February 12, 2026accessdata.fda.gov
September 25, 1991P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF67February 23, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 24, 202392271Class IIIOngoingAlinity i Anti-TPO Reagent Kit, List Number 09P3521Due 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).accessdata.fda.gov

Compare with other makers

Updated June 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.