Company ยท IE
Abbott Ireland Diagnostics Division
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2023. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 |
| CHP | Radioimmunoassay, Estradiol | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| MRG | System, Test, Vitamin D | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 2023 | K223317 | Alkaline Phosphatase2 Abbott Ireland Diagnostics Division, IE | CJE |
| Dec 29, 2022 | K223324 | Total Bilirubin2 Abbott Ireland Diagnostics Division, IE | CIG |
| Jun 30, 2022 | K203597 | Cholesterol2 Abbott Ireland Diagnostics Division, IE | CHH |
| May 31, 2022 | K203771 | Urea Nitrogen2 Abbott Ireland Diagnostics Division, IE | CDQ |
| May 26, 2022 | K210633 | Amylase2 Abbott Ireland Diagnostics Division, IE | JFJ |
| Mar 22, 2022 | K210452 | Creatinine2 Abbott Ireland Diagnostics Division, IE | CGX |
| Mar 18, 2022 | K203530 | Albumin BCP2 Abbott Ireland Diagnostics Division, IE | CJW |
| Nov 23, 2021 | K203248 | Albumin BCG2 Abbott Ireland Diagnostics Division, IE | CIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2019 | Abbott Ireland Diagnostics Division Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in ser Terminated |
CHP | None listed |
| Feb 5, 2019 | Abbott Ireland Diagnostics Division Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human se Terminated |
CHP | None listed |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Ferritin Reagent Kit, List Number 07P6530
The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human s Terminated |
DBF | K983759 |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 Terminated |
MRG | K153375 |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Progesterone Reagent Kit, List Number 08P3620 Terminated |
JLS | None listed |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Estradiol Reagent Kit, List Number 07P5020 Terminated |
CHP | None listed |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 Terminated |
DHA | K170317 |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Free T4 Reagent Kit, List Number 07P7030 Terminated |
CEC | K173122 |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i TSH Reagent Kit, List Number 07P4830 Terminated |
JLW | K983442 |
| Oct 12, 2018 | Abbott Ireland Diagnostics Division ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms
Product Usage:
It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free Terminated |
CDP | None listed |
| Oct 12, 2018 | Abbott Ireland Diagnostics Division ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms
Product Usage:
It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free Terminated |
CDP | None listed |
| Dec 3, 2014 | Abbott Ireland Diagnostics Division ARCHITECT Total T3 Reagent Kit (7K64) consists of:
- 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% so Terminated |
CDP | K983439 |