Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005094123

FEI Number

3005094123

Entity Name

ABBOTT IRELAND DIAGNOSTICS DIVISION

City/State/Country

Longford, IE

Establishment Address

Lisnamuck, Longford -, IE

Establishment Type(s)

Manufacture 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alinity c Iron Reagent Kit (LN 08P3920) Iron2 (Alinity c, LN 04T9820) Iron2 (ARCHITECT, LN 04T0230) Iron2 (ARCHITECT, LN 04T0220) Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030) Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430) Alinity i STAT High Sensitivity Troponin-I (LN 04Z2125, 04Z2135) ARCHITECT Total T4 Calibrators (LN 7K66-01) ARCHITECT Total T4 Controls (LN 7K66-10, 7K66-12) ARCHITECT Total T4 Reagent Kit (LN 7K66-25, 7K66-30, 7K66-35, 7K66-27, 7K66-32, 7K66-37) Alinity i Total T4 Reagent Kit (LN 07P9520, 07P9530) Alinity c Phosphorus Reagent Kit (LN 08P4020, 08P4030) Phosphorus2 (Alinity c, LN 04U0320, 04U0330) Phosphorus2 (ARCHITECT, LN 04T0720, 04T0730) ARCHITECT Free T4 Calibrators (LN 7K65-02) ARCHITECT Free T4 Controls (LN 7K65-10) ARCHITECT Free T4 Reagent Kit (LN 7K65-27, 7K65-32, 7K65-35) Alinity c Rheumatoid Factor Reagent Kit (LN 04R9921) Rheumatoid Factor Calibrator (LN 8G67-02) Rheumatoid Factor (Alinity c, LN 04R9924) RHEUMATOID FACTOR (RF) (LN 8G66-21) Rheumatoid Factor (ARCHITECT, LN 08G6624) Creatinine2 (Alinity c, LN 04T9120) Creatinine2 (ARCHITECT, LN 04S9520) Amylase2 (04S89-20, 04T8520) Uric Acid2 (ARCHITECT; LN 04T1320, 04T1330) ARCHITECT FERRITIN Controls (LN 7K59-10) ARCHITECT FERRITIN Reagent Kit (LN 7K59-25, 7K59-35) ARCHTIECT FERRITIN Calibrators (LN 7K59-01) Alinity i Ferritin Reagent Kit (LN 07P6520, 07P6530) ARCHITECT LH Calibrators (LN 2P40-01) 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) ARCHITECT Free T4 Reagent Kit (LN 7K65-29, 7K65-34, 7K65-39) Alinity i Free T4 Reagent Kit (LN 07P7020, 07P7030) ARCHITECT TOTAL B-HCG Controls (LN 7K78-10) ARCHITECT TOTAL B-HCG Calibrators (LN 7K78-01) ARCHITECT TOTAL B-HCG Reagent Kit (LN 7K78-25, 7K78-30, 7K78-35) Cholesterol2 (Alinity c, LN 04T8830) Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 ) ARCHITECT Estradiol Reagent Kit (LN 7K72-25, 7K72-35) ARCHITECT Estradiol Manual Diluent (LN 7K72-50) Alinity i Estradiol Reagent Kit (LN 07P5020, 07P5030) Alinity i Estradiol Manual Diluent Kit (LN 07P5040) TOTAL PROTEIN (LN 7D73-21, 7D73-22) Alinity c Total Protein Reagent Kit (LN 07P5220) Total Protein2 (ARCHITECT; LN 04U4420, 04U4430) Total Protein2 (Alinity c; LN 04T8120, 04T8130) ARCHITECT TSH Calibrators (LN 7K62-01) ARCHITECT TSH Controls (LN 7K62-10) ARCHITECT TSH Reagent Kit (LN 7K62-25, 7K62-30, 7K62-35) Alinity i TSH Reagent Kit (LN 07P4820, 07P4830) ARCHITECT FSH Reagent Kit (LN 7K75-25, 7K75-35) Alinity i FSH Reagent Kit (LN 07P4920, 07P4930) Alinity c Aspartate Aminotransferase Reagent Kit (LN 08P1720) Alinity c Activated Apartate Aminotransferase Reagent Kit (LN 08P2320) Activated Aspartate Aminotransferase (LN 8L91-22, 8L91-42) Aspartate Aminotranserase (LN 7D81-22) Aspartate Aminotransferase2 (ARCHITECT; LN 04S9020, 04S9030) Activated Aspartate Aminotransferase (ARCHITECT, LN 08L9124, 08L9144) Activated Aspartate Aminotransferase (A-AST) (Alinity c, LN 08P2324) Aspartate Aminotransferase2 (Alinity c; LN 04T8620,04T8630) GAMMA-GLUTAMYL TRANSFERASE (GGT) (LN 7D65-21, 7D65-22, 7D65-42) Alinity c Gamma-Glutamyl Transferase Reagent Kit (LN 07P7320, 07P7330) Gamma-Glutamyl Transferase2 (ARCHITECT; LN 04T0020, 04T0030) Gamma-Glutamyl Transferase2 (Alinity c; LN 04T9620, 04T9630) Alinity c Lactic Acid Reagent Kit (LN 08P2120, 08P2121) Lactic Acid (LN 09P1821) Lactic Acid2 (Alinity c, LN 04U2620) Lactic Acid2 (ARCHITECT, LN 04T3020) Alinity c Apolipoprotein B Reagent Kit (LN 09P4720) Apolipoprotein B (Alinity c, LN 09P4724) Apolipoprotein B (ARCHITECT, LN 09D9324) APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22) Haptoglobin (LN 9D91-21) Alinity c Haptoglobin Reagent Kit (LN 09P5920) Haptoglobin (Alinity c, LN 09P5924) Haptoglobin (ARCHITECT, LN 09D9124) Transferrin (LN 1E04-21, 1E04-22, 1E04-42) Alinity c Transferrin Reagent Kit (LN 08P3820) Transferrin (Alinity c, LN 08P3824) Transferrin (ARCHITECT, LN 01E0424 and 01E0444) Alinity i B12 Reagent Kit (LN 07P6721, 07P6731) ARCHITECT B12 Controls (LN 7K61-12) ARCHITECT B12 Calibrators (LN 7K61-02) ARCHITECT B12 Reagent Kit (LN 7K61-27, 7K61-37) Albumin BCP2 (ARCHITECT, LN 04U4520 and 04U4530) Albumin BCP2 (Alinity c, LN 04T8220 and 04T8230) Immunoglobulin A (IgA) (LN 9D98-21, 9D98-22) Specific Proteins Multiconstituent Calibrator (LN 1E78-02) Alinity c Immunoglobulin A Reagent Kit (LN 09P6120) Immunoglobulin A (IgA) (Alinity c, LN 09P6124) Immunoglobulin A (IgA) (ARCHITECT, LN 09D9824) 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 Prolactin Reagent Kit (LN 7K76-25, 7K76-35) Alinity i Prolactin Reagent Kit (LN 07P6620, 07P6630) Lipase2 Calibrator (LN 04U0001, 04T0401) LIPASE (LN 7D80-31) Lipase2 (LN 04T0420, 04U0020) Alinity i STAT High Sensitivity Troponin-I Reagent Kit (LN 04Z2125, 04Z2135) ARCHITECT Total T3 Calibrators (LN 7K64-01) ARCHITECT Total T3 Manual Diluent (7K64-50) ARCHITECT Total T3 Reagent Kit (LN 7K64-25, 7K64-35, 7K64-27, 7K64-32, 7K64-37) Alinity i Total T3 Manual Diluent (LN 07P9440) Alinity i Total T3 Reagent Kit (LN 07P9420, 07P9430) Total Bilirubin2 (Alinity c, LN 04U0520) Total Bilirubin2 (ARCHITECT, LN 04T0920 and 04T0930) ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit (LN 2R98-25, 2R98-35) Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503) Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201) Alinity c Multiconstituent Calibrator Kit (LN 08P6001) Alinity c ICT Urine Calibrator Kit (LN 08P7001) ICT Urine Calibrator (LN 1E47-03) Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601) Alinity c ICT Serum Calibrator Kit (LN 08P6901) Alinity c Proteins Calibrators (LN 08P6702) ICT Serum Calibrator (LN 1E46-04) Alinity i Anti-CCP Calibrators (LN 09P2701) Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403) Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201) Alinity c Bilirubin Calibrator Kit (LN 08P6101) Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101) Alinity c Iron Calibrator Kit (LN 04U7501) Bilirubin Calibrator (LN 1E66-05) Urine/CSF Protein Calibrator (LN 1E71-03) Carbon Dioxide Calibrator (LN 1E64-03) Specific Proteins Multiconstituent Calibrator (LN 1E78-04) Multiconstituent Calibrator (LN 1E65-06) Lipid Multiconstituent Calibrator (LN 5P56-02) Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501) Consolidated Chemistry Calibrator (Alinity c; LN 04V6201) ARCHITECT FSH CALBRATORS (LN 7K75-01) ARCHITECT PROLACTIN CALIBRATORS (LN 7K76-01) ARCHITECT PROGESTERONE CALIBRATORS (LN 7K77-01) ARCHITECT PROGESTERONE CONTROLS (LN 7K77-10) ARCHITECT FSH CONTROLS (LN 7K75-10) ARCHITECT ESTRADIOL CALIBRATORS (LN 7K72-01) ARCHITECT PROLACTIN CONTROLS (LN 7K76-10) ARCHITECT ESTRADIOL CONTROLS (LN 7K72-10) ARCHITECT LH Reagent Kit (LN 2P40-25, 2P40-35) Alinity i LH Reagent Kit (LN 07P9120, 07P9130) Walgreens Ovulation Predictor Test CVS Ovulation Predictor Test Rite Aid Ovulation Predictor Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2018-09-25
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-07-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2023-05-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2007-12-07
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2018-06-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-04-11
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2013-04-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-04-11
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2007-12-07
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2024-07-15
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2025-11-21
CDO	Acid, Uric, Uricase (U.V.)	Clinical Chemistry	Class 1	862.1775	2022-04-13
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2007-11-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-06-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-11-22
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2018-04-19
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-12-07
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2025-02-05
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1998-07-16
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-04-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2007-12-07
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	1999-02-12
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2018-05-14
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2000-12-26
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	1999-12-03
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2007-12-07
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1999-01-12
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-06-25
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2012-06-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-06-25
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-07-16
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-07
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
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1996-02-14
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2003-08-04
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2022-06-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2024-07-15
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2024-07-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2019-10-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-11-30
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-18
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1999-02-12

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
K171566	Siemens Healthcare Diagnostics, Inc.	Atellica IM High-Sensitivity Troponin I (TNIH)	2018-07-19
K182225	Siemens Healthcare Diagnostics, Inc.	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	2019-03-04
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2009	Roche Diagnostics Corp.	1	Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma.
Z-0011-2009	Roche Diagnostics Corp.	2	Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of albumin concentration in serum and plasma.
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
1220972	MEDICA CORP.	BEDFORD, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005094123. Last updated year: 2026. Please use registration number 3005094123 when referencing this establishment in official correspondence.