Alkaline Phosphatase2
Abbott Ireland Diagnostics Division
ABBOTT IRELAND DIAGNOSTICS DIVISION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005094123 | 3005094123 | ABBOTT IRELAND DIAGNOSTICS DIVISION | 1 | N | 2027-01-01 | Lisnamuck Longford IE - |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 114708 | 1757070345 | K983759 | ABBOTT ARCHITECT FERRITIN | DBF | 1998-12-07 |
| 114708 | 1128228408 | K983442 | ABBOTT ARCHITECT TSH | JLW | 1998-11-20 |
| 114708 | 1632719028 | K983441 | C3 | CZW | 1998-11-04 |
| 114708 | 1596630445 | K983440 | ABBOTT ARCHITECT TOTAL T4 | KLI | 1998-11-25 |
| 114708 | 1138439833 | K983439 | ABBOTT ARCHITECT FREE T3 | CDP | 1998-11-20 |
| 114708 | 1066930130 | K983434 | ABBOTT ARCHITECT TOTAL T3 | CDP | 1998-11-20 |
| 114708 | 1446967412 | K983424 | ABBOTT ARCHEITECT TOTAL B-HCG | DHA | 1998-12-01 |
| 114708 | 1971712753 | K983359 | IGA | CZP | 1998-11-04 |
| 114708 | 1491571274 | K983356 | C4 | DBI | 1998-11-04 |
| 114708 | 2049809977 | K983289 | APOLIPOPROTEIN A1 | DER | 1999-01-29 |
| 114708 | 1571696246 | K983281 | APOB | DFC | 1999-01-26 |
| 114708 | 1263096791 | K983221 | IGG | DEW | 1998-11-04 |
| 114708 | 1361119208 | K983167 | TRF | DDG | 1998-11-04 |
| 114708 | 1277809958 | K983132 | IGM | DFT | 1998-11-04 |
| 114708 | 1402866553 | K252357 | Glucose2 | CFR | 2025-10-24 |
| 114708 | 1479988809 | K230994 | Alinity i STAT High Sensitivity Troponin-I | MMI | 2023-05-04 |
| 114708 | 1409163087 | K223324 | Total Bilirubin2 | CIG | 2022-12-29 |
| 114708 | 1102197463 | K223317 | Alkaline Phosphatase2 | CJE | 2023-07-21 |
| 114708 | 1942038913 | K210633 | Amylase2 | JFJ | 2022-05-26 |
| 114708 | 1646036763 | K210452 | Creatinine2 | CGX | 2022-03-22 |
| 114708 | 2020778306 | K203597 | Cholesterol2 | CHH | 2022-06-30 |
| 114708 | 1786443780 | K203530 | Albumin BCP2 | CJW | 2022-03-18 |
| 114708 | 1534300189 | K203248 | Albumin BCG2 | CIX | 2021-11-23 |
| 114708 | 1085569000 | K202525 | Alinity i STAT High Sensitivity Troponin-I | MMI | 2022-05-19 |
| 114708 | 1112874795 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | MMI | 2019-09-13 |
| 114708 | 1372859818 | K181748 | Magnesium | JGJ | 2018-09-12 |
| 114708 | 1856662227 | K173122 | Abbott Architect Free T4 | CEC | 2017-10-27 |
| 114708 | 2037553514 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | DHA | 2017-10-23 |
| 114708 | 1738223887 | K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | CFR | 2017-10-19 |
| 114708 | 1439835765 | K170160 | Abbott ARCHITECT Free T3 | JIT | 2017-02-15 |
| 114708 | 1307909812 | K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | MRG | 2016-08-12 |
| 114708 | 1840620959 | K151566 | Abbott ARCHITECT Total T4 Calibrators | JIT | 2015-07-10 |
| 114708 | 2062421044 | K123379 | ABBOTT ARCHITECT FREE T4 | CEC | 2012-11-27 |
| 114708 | 1010283374 | K121314 | ARCHITECT B12 | CDD | 2012-05-17 |
| 114708 | 2003015212 | K111023 | ABBOTT ARCHITECT LH CALIBRATORS | JIT | 2011-06-10 |
| 114708 | 1655484019 | K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | CGN | 2010-03-05 |
| 114708 | 1665855756 | K041687 | ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR | JJX | 2004-08-18 |
| 114708 | 1494265528 | K032458 | ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT | JIT | 2003-10-06 |
| 114708 | 1836989648 | K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | JIS | 2003-04-11 |
| 114708 | 1409177139 | K024067 | RHEUMATOID FACTOR (RF) | DHR | 2003-01-15 |
| 114708 | 1027820589 | ||||
| 114708 | 1094219453 | ||||
| 114708 | 1160007666 | ||||
| 114708 | 1163804235 | ||||
| 114708 | 1208149217 | ||||
| 114708 | 1212461448 | ||||
| 114708 | 1250460448 | ||||
| 114708 | 1293892900 | ||||
| 114708 | 1334601692 | ||||
| 114708 | 1350240723 | ||||
| 114708 | 1361535590 | ||||
| 114708 | 1374215066 | ||||
| 114708 | 1563580263 | ||||
| 114708 | 1628318929 | ||||
| 114708 | 1637818845 | ||||
| 114708 | 1775213264 | ||||
| 114708 | 1789023897 | ||||
| 114708 | 1819473248 | ||||
| 114708 | 1952141865 | ||||
| 114708 | 2031108156 | ||||
| 114708 | 2063312153 | ||||
| 114708 | 2068722444 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JIT | 4 | 2017-02-15 |
| MMI | 3 | 2023-05-04 |
| CFR | 2 | 2025-10-24 |
| CEC | 2 | 2017-10-27 |
| DHA | 2 | 2017-10-23 |
| CDP | 2 | 1998-11-20 |
| CJE | 1 | 2023-07-21 |
| CIG | 1 | 2022-12-29 |
| CHH | 1 | 2022-06-30 |
| JFJ | 1 | 2022-05-26 |
| CGX | 1 | 2022-03-22 |
| CJW | 1 | 2022-03-18 |
| CIX | 1 | 2021-11-23 |
| JGJ | 1 | 2018-09-12 |
| MRG | 1 | 2016-08-12 |
| CDD | 1 | 2012-05-17 |
| CGN | 1 | 2010-03-05 |
| JJX | 1 | 2004-08-18 |
| JIS | 1 | 2003-04-11 |
| DHR | 1 | 2003-01-15 |
| DER | 1 | 1999-01-29 |
| DFC | 1 | 1999-01-26 |
| DBF | 1 | 1998-12-07 |
| KLI | 1 | 1998-11-25 |
| JLW | 1 | 1998-11-20 |
| DDG | 1 | 1998-11-04 |
| DBI | 1 | 1998-11-04 |
| CZW | 1 | 1998-11-04 |
| DFT | 1 | 1998-11-04 |
| CZP | 1 | 1998-11-04 |
| DEW | 1 | 1998-11-04 |
PMN#
Total Bilirubin2
Abbott Ireland Diagnostics Division
Cholesterol2
Abbott Ireland Diagnostics Division
Urea Nitrogen2
Abbott Ireland Diagnostics Division
Amylase2
Abbott Ireland Diagnostics Division
Creatinine2
Abbott Ireland Diagnostics Division
Albumin BCP2
Abbott Ireland Diagnostics Division
Albumin BCG2
Abbott Ireland Diagnostics Division