FDA Registration
Active
🇮🇪 Ireland
ABBOTT IRELAND DIAGNOSTICS DIVISION
Reg #: 3005094123
·
FEI: 3005094123
·
Expires 2026
Products
53
Proprietary Names
349
Establishment Types
4
Classifications
53
Registration Details
- Registration Name
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Registration Number
- 3005094123
- FEI Number
- 3005094123
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lisnamuck
- City
- Longford
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K203248
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- ABBOTT LABORATORIES
- Contact Name
- Sara Qadri
- Address
- 675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 6680142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2018-09-25 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2024-07-15 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2023-05-05 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-12-07 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2018-06-02 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2013-04-11 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2007-12-07 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2024-07-15 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2025-11-21 |
| Acid, Uric, Uricase (U.V.) | CDO | Class 1 | Clinical Chemistry | No | 2022-04-13 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2007-11-05 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2025-02-05 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 1998-07-16 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2012-04-19 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 1999-02-12 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2018-05-14 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2000-12-26 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 1999-12-03 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2007-12-07 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 1999-01-12 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2007-12-07 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2012-06-25 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2024-07-16 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2007-12-07 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-05-03 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 1996-02-14 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2003-08-04 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2024-07-15 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2024-07-15 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2017-11-30 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1999-02-12 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2018-06-02 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2000-12-26 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-04-16 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 1999-01-12 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2019-09-25 |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2019-09-25 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2007-12-07 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2007-12-07 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2010-03-08 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2007-12-19 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2016-10-24 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2007-12-07 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 1999-02-12 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 1999-01-13 |
| Alpha-1-Lipoprotein, Antigen, Antiserum, Control | DER | Class 2 | Immunology | No | 2007-12-07 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2025-12-02 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2018-12-18 |
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
Alinity c Uric Acid Reagent Kit (LN 08P5620, 08P5630)
Uric Acid (LN 3P39-22, 3P39-42)
Uric Acid2 (Alinity c; LN 04U0920, 04U0930)
ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22)
ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42)
Alinity c Alanine Aminotransferase Reagent Kit (LN 07P9820)
Alinity c Activated Alanine Aminotransferase Reagent Kit (LN 08P1820)
Alanine Aminotransferase2 (Alinity c; LN 04T8420, 04T8430)
Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824)
Alanine Aminotransferase2 (ARCHITECT; LN 04S8820, 04S8830)
Activated Alanine Aminotransferase (ARCHITECT, LN 08L9224, 08L9244)
ARCHITECT Free T3 Calibrators (LN 7K63-02)
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)
LACTATE DEHYDROGENASE (LDH) (LN 2P56-21, 2P56-22, 2P56-42)
Alinity c Lactate Dehydrogenase Reagent Kit (LN 07P7420, 07P7430)
Lactate Dehydrogenase2 (LN 04T0320, 04T0330, 04T9920, 04T9930)
Alinity c Microalbumin Calibrators - LN 08P0401
Microalbumin Calibrators - LN 02K9802 and 02K9803
Alinity c Microalbumin Reagent Kit - LN 08P0420
Microalbumin - LN 02K9820 and 02K9821
Alinity c Microalbumin Controls - LN 08P0410
Microalbumin Controls - LN 02K9810 and 02K9811
Microalbumin Controls (ARCHITECT; LN 02K9814)
Microalbumin (Alinity c, LN 08P0424)
Microalbumin Controls (Alinity c, LN 08P0414)
Microalbumin (ARCHITECT; LN 02K9824)
Microalbumin Calibrators (Alinity c, LN 08P0404)
Microalbumin Calibrators (ARCHITECT; LN 02K9804)
Complement C3 (LN 9D96-21, 9D96-22)
Alinity c Complement C3 Reagent Kit (LN 09P5620)
Complement C3 (ARCHITECT, LN 09D9624)
Complement C3 (Alinity c, LN 09P5624)
Cystatin C Calibrators (LN 06T3201)
Alinity i Syphilis TP Calibrator (LN 07P6001)
Alinity i Progesterone Calibrators (LN 08P3601)
Alinity i 25-OH Vitamin D Calibrators (LN 08P4501)
Alinity i Total T4 Calibrators (LN 07P9501)
Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801)
Alinity i FSH Calibrators (LN 07P4901)
Alinity i Free T4 Calibrators (LN 07P7001)
Alinity i B12 Calibrators (LN 07P6702)
Alinity c UIBC Calibrator Kit (LN 08P4401)
Alinity i Prolactin Calibrators (LN 07P6601)
Alinity i Total B-hCG Calibrators (LN 07P5101)
Alinity i TSH Calibrators (LN 07P4801)
Alinity c Hemoglobin A1c Calibrators (LN 08P4301)
Alinity i C-Peptide Calibrators (LN 09P3601)
Alinity i Ferritin Calibrators (LN 07P6501)
Alinity i Intact PTH Calibrators (LN 08P3102)
Alinity i Estradiol Calibrators (LN 07P5001)
Lipase NG OC Calibrator (LN 04Y8501)
Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601)
Alinity i LH Calibrators (LN 07P9101)
Alinity i Anti-TPO Calibrators (LN 09P3501)
Alinity i T-Uptake Calibrators (LN 08P1201)
Alinity i Folate Calibrators (LN 08P1402)
Alinity c B2-Microglobulin Calibrator (LN 01R0902)
Alinity i Insulin Calibrators (LN 04T7501)
Alinity c Prealbumin Calibrator Kit (LN 04S0101)
Alinity i CA 15-3 Calibrators (LN 08P5101)
Alinity i Anti-Tg Calibrators (LN 09P3401)
Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002)
Alinity i Cortisol Calibrators (LN 08P3301)
Alinity c Lp(a) Calibrators (LN 01R1401)
Alinity i CA 125 II Calibrators (LN 08P4901)
Alinity i DHEA-S Calibrators (LN 09P3701)
Alinity i Homocysteine Calibrators (LN 09P2801)
Alinity c ASO Calibrator (LN 01R0602)
Alinity i Total T3 Calibrators (LN 07P9401)
ARCHITECT Insulin Calibrators (LN 08K4103)
Alinity i HE4 Calibrators (LN 08P5001)
Alinity i CA 19-9XR Calibrators (LN 08P3201)
ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01)
ARCHITECT Total T3 Calibrators (LN 7K64-02)
Alinity i Free T3 Calibrators (LN 07P6901)
Alinity i Tacrolimus Calibrators (LN 09P4201)
Prealbumin Calibrator (LN 6E57-03)
Alinity i Sirolimus Calibrators (LN 09P4101)
Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101)
Acetaminophen Calibrator (LN 03R7401)
Acetaminophen Calibrator (Alinity c, LN 07P5401)
UCH-L1 Calibrators (Alinity i, LN 04W1901)
GFAP Calibrators (ARCHITECT, LN 4W16-01)
Alinity i BRAHMS PCT Calibrators (LN 01R1801)
GFAP Calibrators (Alinity i, LN 04W1701)
Alere NT-proBNP for Alinity i Calibrators (LN 04S7902)
ACE Calibrator (LN 06U8601)
UCH-L1 Calibrators (ARCHITECT, LN 4W18-01)
ACE Calibrator (LN 06U8201)
Alinity i CMV IgG Calibrators (LN 07P4202)
Complement C4 (LN 9D97-21, 9D97-22)
Alinity c Complement C4 Reagent Kit (LN 09P5720)
Complement C4 (Alinity c, LN 09P5724)
Complement C4 (ARCHITECT, LN 09D9724)
ARCHITECT Folate Manual Diluent (LN 1P74-50)
ARCHITECT Folate Reagent Kit (LN 1P74-27, 1P74-37)
Alinity i Folate Reagent Kit (LN 08P1421, 08P1431)
Alinity i Folate Manual Diluent (08P1460)
ARCHITECT Folate Calibrators (LN 1P74-02)
ARCHITECT Folate Controls (LN 1P74-12)
Immunoglobulin M (IgM) (LN 1E01-21, 1E01-22)
Alinity c Immunoglobulin M Reagent Kit (LN 09P6320)
Immunoglobulin M (IgM) (Alinity c, LN 09P6324)
Immunoglobulin M (IgM) (ARCHITECT, LN 01E0124)
ARCHITECT 25-OH Vitamin D Calibrators (LN 5P02-02)
ARCHITECT 25-OH Vitamin D Controls (LN 5P02-12)
ARCHITECT 25-OH Vitamin D Reagent Kit (LN 5P02-25, 5P02-30, 5P02-35)
Alinity i 25-OH Vitamin D Reagent Kit (08P4522, 08P4532)
Immunoglobulin G (IgG) (LN 9D99-21, 9D99-22)
Aliniity c Immunoglobulin G Reagent Kit (LN 09P6220)
Immunoglobulin G (IgG) (Alinity c, LN 09P6224)
Immunoglobulin G (IgG) (ARCHITECT, LN 09D9924)
ARCHITECT Total T4 Calibrators (LN 7K66-02)
ARCHITECT Progesterone Manual Diluent (LN 7K77-50)
ARCHITECT Progesterone Reagent Kit (LN 7K77-25, 7K77-35)
Alinity i Progesterone Reagent Kit (LN 08P3620, 08P3630)
Alinity i Progesterone Manual Diluent Kit (LN 08P3640)
PREALBUMIN (LN 1E02-21, 1E02-22, 01E0224)
Prealbumin Calibrator (LN 6E57-02)
Alinity c Prealbumin Reagent Kit (LN 09P8620)
Prealbumin (Alinity c, LN 09P8624)
APOLIPOPROTEIN A1 (ApoA) (LN 9D92-21, 9D92-22)
Alinity c Apolipoprotein A1 Reagent Kit (LN 09P4620)
Apolipoprotein A1 (Alinity c, LN 09P4624)
Apolipoprotein A1 (ARCHITECT, LN 09D9224)
ARCHITECT Free T3 Reagent Kit (LN 7K63-25, 7K63-35, 7K63-27, 7K63-32, 7K63-37)
ARCHITECT Free T3 Calibrators (LN 7K63-01)
ARCHITECT Free T3 Controls (LN 7K63-10, 7K63-12)
Alinity i Free T3 Reagent Kit (LN 07P6920, 07P6930)
Architect Alkaline Phosphatase2 (LN 04S8720, 04S8730)
Alinity Alkaline Phosphatase2 (LN 04T8320, 04T8330)
Magnesium (LN 3P68-22, 3P68-32)
Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930)
Magnesium (Alinity c; LN 08P1925, 08P1934)
Magnesium (ARCHITECT; LN 03P6824, 03P6834)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)