ABBOTT IRELAND

FDA Device Registration & Listing · SLIGO, IE · Registration 3008344661

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008344661
FEI Number
3008344661
Entity Name
ABBOTT IRELAND
City/State/Country
SLIGO, IE
Establishment Address
DIAGNOSTICS DIVISION, FINISKLIN BUSINESS PARK, SLIGO -, IE
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K052308
PMA Number
N/A

All Registered Proprietary Names

Alinity i T-Uptake Reagent Kit (LN 08P1220) ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825) Alinity h-series Phosphate Buffer (LN 07P8301) ARCHITECT Free PSA Reagent Kit (LN 6C07-27) ARCHITECT Free PSA Calibrators (LN 6C07-01) ARCHITECT Free PSA Controls (LN 6C07-10) Alinity i Free PSA Controls (LN 07P9310) Alinity i Free PSA Calibrators (LN 07P9301) Alinity i Free PSA Reagent Kit (LN 07P9321, 07P9331) Alinity i Anti-TPO Reagent Kit (LN 09P3521) ARCHITECT Anti-TPO Calibrators (LN 2K47-01) ARCHITECT Anti-TPO Reagent Kit (LN 2K47-27) ARCHITECT Anti-TPO Controls (LN 2K47-10) Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131) Alinity i System Accessories Alinity i System Alinity i Refurbished Processing Module (LN 03R65-84) ARCHITECT AFP Calibrators (LN 3P36-01) ARCHITECT AFP Reagent Kit (LN 3P36-25, 3P36-35) ARCHITECT AFP Controls (LN 3P36-10) Alinity i AFP Reagent Kit (LN 07P9020, 07P9030) Alinity i AFP Controls (LN 07P9010) Alinity i AFP Calibrators (LN 07P9001) ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35) ARCHITECT Total PSA Controls (LN 6C06-10) ARCHITECT Total PSA Calibrators (LN 6C06-01) Alinity i Total PSA Controls (LN 07P9210) Alinity i Total PSA Calibrators (LN 07P9201) Alinity i Total PSA Reagent Kit (LN 07P9221, 07P9231) Alinity i Cortisol Reagent Kit (LN 08P3320, 08P3330) ARCHITECT Cortisol Calibrators (LN 8D15-02) ARCHITECT Cortisol Reagent Kit (LN 8D15-25, 8D15-35) ARCHITECT HBsAg Next Confirmatory Reagent Kit (LN 4P77-27) ARCHITECT HBsAg Next Qualitative Reagent Kit (LN 4P76-27, 4P76-37, 4P76-32) ARCHITECT HBsAg Next Qualitative Calibrators (LN 4P76-02) Alinity i HBsAg Next Qualitative Calibrators (LN 01R6402) Alinity i HBsAg Next Qualitative Controls (LN 01R6412) Alinity i HBsAg Next Confirmatory Manual Diluent (LN 01R6542) ARCHITECT HBsAg Next Qualitative Controls (LN 4P76-12) ARCHITECT HBsAg Next Confirmatory Manual Diluent (LN 4P77-42) Alinity i HBsAg Next Confirmatory Reagent Kit (LN 01R6521) Alinity i HBsAg Next Qualitative Reagent Kit (LN 01R6421, 01R6431) GFAP Reagent Kit (ARCHITECT, LN 4W16-27) UCH-L1 Reagent Kit (ARCHTECT, LN 4W18-27) Alinity h-series WBC Reagent (LN 07P7904) ARCHITECT HBsAg Qualitative Controls (LN 4P53-10) ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01) Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (LN 08P1141) Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (LN 08P1121) Alinity i HBsAg Qualitative II Reagent Kit (LN 08P1021, 08P1031) Alinity i HBsAg Qualitative II Controls (LN 08P1012) ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit (LN 4P54-25) Alinity i HBsAg Qualitative II Calibrators (LN 08P1002) ARCHITECT HBsAg Qualitative Reagent Kit (LN 4P53-25, 4P53-35) ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent (LN 4P54-40) SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30) AdviseDx SARS-CoV-2 IgM Calibrator Kit (Alinity i, LN 06R9101) SARS-CoV-2 IgG Calibrator Kit (Alinity i, LN 06R9001) SARS-CoV-2 IgG Reagent Kit (Alinity i, LN 06R9020, 06R9030) SARS-CoV-2 IgG Control Kit (Alinity i, LN 06R9010) SARS-CoV-2 IgG Control Kit (ARCHITECT, LN 6R86-10) AdviseDx SARS-CoV-2 IgG II Control Kit (ARCHITECT, LN 6S60-10) AdviseDx SARS-CoV-2 IgG II Control Kit (Alinity i, LN 06S6110) AdviseDx SARS-CoV-2 IgM Control Kit (Alinity i, LN 06R9110) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (Alinity i, LN 06S6101) AdviseDx SARS-CoV-2 IgM Control Kit (ARCHITECT, LN 06R8710) AdviseDx SARS-CoV-2 IgM Reagent Kit (Alinity i, LN 06R9120, 06R9130) SARS-CoV-2 IgG Calibrator Kit (ARCHITECT, LN 6R86-01) AdviseDx SARS-CoV-2 IgM Reagent Kit (ARCHITECT, LN 06R8720, 06R8730) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (ARCHITECT, LN 6S60-01) AdviseDx SARS-CoV-2 IgM Calibrator Kit (ARCHITECT, LN 06R8701) AdviseDx SARS-CoV-2 IgG II (ARCHITECT, LN 6S60-20, 6S60-30) AdviseDx SARS-CoV-2 IgG II (Alinity i, LN 06S6120, 06S6130) Alinity i HSV-2 IgG Calibrator (LN 04W2102) Alinity i HSV-2 IgG Reagent Kit (LN 04W2127, 04W2137) Alinity i HSV-2 IgG Controls (LN 04W2112) ARCHITECT Transplant Pretreatment Tubes (LN 1P06-02) Transplant Pretreatment Tubes (LN 1P06-03) ARCHITECT Sirolimus Reagent Kit (LN 1L76-25) ARCHITECT Sirolimus Calibrators (LN 1L76-01) ARCHITECT Sirolimus Whole Blood Precipitation Reagent (LN 1L76-55) Alinity i Sirolimus Whole Blood Precipitation Reagent (LN 09P4140) Alinity i Sirolimus Reagent Kit (LN 09P4120) Alinity i STAT Myoglobin Reagent Kit (LN 04V3720, 04V3730) ARCHITECT STAT Myoglobin Reagent Kit (LN 2K43-20, 2K43-25) ARCHITECT STAT Myoglobin Calibrators (LN 2K43-01) CELL-DYN Sapphire System Reticulocyte Reagent (LN 01H76-01) Alinity h-series Retic Reagent (LN 07P8004) CELL-DYN Reticulocyte Reagent (LN 03H40-01) Alinity i CMV IgG Reagent Kit (LN 07P4224, 07P4233) Transplant Pretreatment Tubes (LN 01P0603) ARCHITECT Tacrolimus Whole Blood Precipitation Reagent (LN 01L7755) Alinity i Tacrolimus Reagent Kit (LN 09P4220) ARCHITECT Tacrolimus Reagent Kit (LN 01L7725) ARCHITECT Transplant Pretreatment Tubes (LN 01P0602) ARCHITECT Tacrolimus Calibrators (LN 01L7701) Alinity i Tacrolimus Whole Blood Precipitation Reagent (LN 09P4240) ACE Control (LN 06U8210) Cystatin C Controls (LN 06T3210) Alinity i Total B-HCG Controls (LN 07P5110) Alinity i Estradiol Controls (LN 07P5010) FreeStyle Control Solution Alinity i Total T4 Controls (LN 07P9510) Alinity i 2nd Generation Testosterone Controls (LN 07P6810) Alinity i Intact PTH Controls (LN 08P3111) Alinity i Prolactin Controls (LN 07P6610) Alinity i Free T4 Controls (LN 7P7010) Alinity i TSH Controls (LN 07P4810) Alinity i Insulin Controls (LN 04T7510) Alinity i FSH Controls (LN 07P4910) Alinity i HE4 Controls (LN 08P5010) Lipase NG OC Control 2 (LN 04Y8511) Alinity i Progesterone Controls (LN 08P3610) Alinity i Syphilis TP Controls (LN 07P6010) Alinity i 25-OH Vitamin D Controls (LN 08P4512) Alinity i CA 125 II Controls (LN 08P4910) Alinity c ASO Control I (LN 04S0912) Alinity c Ammonia Controls (LN 08P2210) Alinity i CA 15-3 Controls (LN 08P5110) ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10) Alinity i CA 19-9XR Controls (LN 08P3210) Lipase NG OC Control 1 (LN 04Y8510) Alinity i Ferritin Controls (LN 07P6510) Alinity c Lp(a) Control Kit (LN 01R1410) Alinity i Homocysteine Controls (LN 09P2810) Alinity i C-Peptide Controls (LN 09P3610) Alinity i Folate Controls (LN 08P1412) Alinity i B12 Controls (LN 07P6712) Alinity i Anti-Tg Controls (LN 09P3410) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610) Alinity c ASO Control II (LN 04S0913) Alinity i DHEA-S Controls (LN 09P3710) Alinity c Hemoglobin A1c Controls (LN 08P4310) Alinity i Anti-TPO Controls (LN 09P3510) Alinity c Cannabinoids Control 2 Kit (LN 09P5411) Alinity c Cannabinoids Control 1 Kit (LN 09P5410) Alinity i T-Uptake Controls (LN 08P1210) ARCHITECT Insulin Controls (LN 08K4112) Alinity i Free T3 Controls (LN 07P6910) MediSense Control Solution Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110) GFAP Controls (Alinity i, LN 04W1710) UCH-L1 Controls (Alinity i, LN 04W1910) GFAP Controls (ARCHITECT, LN 4W16-10) Alinity i BRAHMS PCT Controls (LN 01R1810) Alere NT-proBNP for Alinity i Controls (LN 04S7911) Alinity i CMV IgG Controls (LN 07P4212) ACE Control (LN 06U8610) UCH-L1 Controls (ARCHITECT, LN 4W18-10) CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02) CELL-DYN CN-Free HGB Reagent (LN 01H79-01) CELL-DYN CN Free HGB/NOC Lyse (LN 03H80-02) CELL-DYN WBC Lyse (LN 08H52-01) CELL-DYN Emerald CN-Free Lyse (LN 09H47-02) CELL-DYN Emerald 22 Lyse (LN 09H6101) Alinity h-series HGB Reagent (LN 07P8104) CELL-DYN WBC Reagent - Part A (LN 01H77-01/01H77-02) Alinity i Rubella IgG Reagent Kit (LN 04W02-22) Alinity i Rubella IgG Calibrators (LN 04W02-01) Alinity i Rubella IgG Controls (LN 04W02-10) Alinity s System Accessories Alinity s System ARCHITECT CEA Reagent Kit (LN 7K68-27, 7K68-32, 7K68-35) ARCHITECT CEA Controls (LN 7K68-12) ARCHITECT CEA Calibrators (LN 7K68-02) Alinity i CEA Calibrators (LN 07P6201) Alinity i CEA Reagent Kit (LN 07P6220, 07P6230) Alinity i CEA Controls (LN 07P6210) Alinity i Anti-Tg Reagent Kit (LN 09P3420) ARCHITECT Anti-Tg Controls (LN 2K46-10) ARCHITECT Anti-Tg Reagent Kit (LN 2K46-20, 2K46-25) ARCHITECT Anti-Tg Calibrators (LN 2K46-01)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2002-05-09
JCC Ph Buffer Pathology Class 1 864.4010 2023-09-27
MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer Unknown Class 3 N/A 2007-12-05
MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions Unknown Class 3 N/A 2007-12-05
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-06-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-06-29
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2018-06-29
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2018-05-03
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2018-05-03
LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown Class 3 N/A 2013-01-14
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2007-12-05
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2007-12-05
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2007-12-05
MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer Unknown Class 3 N/A 2007-12-05
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-12-05
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-06-29
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2018-06-29
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2023-02-08
QAT Brain Trauma Assessment Test Immunology Class 2 866.5830 2024-01-29
GGJ Fluid, Diluting, White-Cell Hematology Class 1 864.8200 2023-09-27
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2012-05-16
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-04-16
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2025-08-27
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2025-08-27
NRP Sirolimus Test System Clinical Toxicology Class 2 862.3840 2019-09-25
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2019-09-25
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2019-05-31
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2019-05-31
GJH Stain, Reticulocyte Hematology Class 1 864.1850 2011-01-12
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2023-05-18
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2019-09-25
MLM Enzyme Immunoassay, Tracrolimus Clinical Chemistry Class 2 862.1678 2019-09-25
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-11-22
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 1994-09-21
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2025-11-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2025-11-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2025-11-19
MZA Test, Equipment, Automated Bloodborne Pathogen Unknown Class N N/A 2016-12-15
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2007-12-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-06-29
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2018-06-29
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2018-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

Sara Qadri Business: ABBOTT LABORATORIES Email: sara.qadri@abbott.com Phone: (224) 6680142

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21
K081789 Siemens Healthcare Diagnostics, Inc. DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR 2008-09-10
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16
K103548 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 2011-06-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008344661. Last updated year: 2026. Please use registration number 3008344661 when referencing this establishment in official correspondence.
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