FDA.report

Abbott Ireland Diabetes Care

Matched from indexed company URL: ABBOTT IRELAND

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30070311033007031103Abbott Ireland Diabetes Care1N2026-01-01Donegal Town, Co. Donegal Donegal Town IE Donegal
30083446613008344661ABBOTT IRELAND1N2026-01-01DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK SLIGO IE -
30333944453033394445Abbott Ireland, ADC Kilkenny1N2026-01-01IDA Ireland Kilkenny Business & Technology Park Ring Road Kilkenny IE R95 A02A

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00380740106003ARCHITECT - ARCHITECT Total Beta hCG Reagent Kit (500T)+1(877)422-2688xx@xx.xx
00380740155322Alinity - Lactate Dehydrogenase2+1(877)422-2688xx@xx.xx
00380740155339Alinity - Lactate Dehydrogenase2+1(877)422-2688xx@xx.xx
00380740155612Alinity - Amylase2+1(877)422-2688xx@xx.xx

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1155311185492289P980007AXSYM FREE PSAMTG2004-02-05
1155311256468909P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF1991-09-25
1155311513741180P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitLOM2022-08-10
1155311316120706P120008ABBOTT ARCHITECT AFP ASSAYLOK2012-11-28
1155311238379979P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLSLOM2012-04-12
1155311697919650P050051ABBOTT ARCHITECT AUSABSEI2006-06-01
1155311059413930K990774ABBOTT ARCHITECT CEADHX1999-05-11
1155311110591424K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF2025-02-12
1155311502685312K243168Alinity i Rubella IgGLFX2025-06-20
3336701906589163K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2024-04-23
1155311378319410K232669TBIQAT2023-09-29
1155311124229904K223602Traumatic brain injury (TBI) testQAT2023-03-02
3336701258269567K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemQBJ2023-03-03
1155311574018327K220949Architect CMV IgGLFZ2022-10-27
1155312033101201K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsPRI2017-06-01
1155312037553514K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA2017-10-23
877551247953832K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR2015-09-17
877551752609291K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemNBW2015-06-05
877551314706277K150332FreeStyle Lite Blood Glucose Monitoring SystemNBW2015-06-05
877551891318144K120568FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMNBW2012-03-29
877551089075446K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23NBW2010-06-15
877551530081385K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemNBW2010-05-14
1155311573002791K070822ARCHITECT SIROLIMUS ASSAYNRP2007-09-28
1155311015615001K070820ARCHITECT TACROLIMUS: MODEL 1L77MLM2007-08-01
1155311880260981K062204ARCHITECT CORTISOL ASSAYJFT2006-09-22
1155311437123803K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSJZO2006-07-18
1155311431936302K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMJZO2006-05-10
1155311803607864K042924ARCHITECT STAT MYO IMMUNOASSAYDDR2005-01-24
1155311124779476K041596ARCHITECT STAT CK-MB IMMUNOASSAYJHX2004-07-21
1155311094219453
1155311209571615
1155311351050201
1155311441485185
1155311563580263
1155311637818845
1155311740613641
1155311776075390
1155311779903801
1155311909949737

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NBW62015-06-05
QBJ22024-04-23
QAT22023-09-29
LOM22012-04-12
JZO22006-07-18
LFX12025-06-20
MYF12025-02-12
LFZ12022-10-27
LOM 12022-08-10
DHA12017-10-23
PRI12017-06-01
LFR12015-09-17
LOK12012-11-28
NRP12007-09-28
MLM12007-08-01
JFT12006-09-22
DDR12005-01-24
JHX12004-07-21
MTG 12004-02-05
DHX11999-05-11
MTF 11991-09-25

PMN

Amylase2

2022-05-26

Abbott Ireland Diagnostics Division

Creatinine2

2022-03-22

Abbott Ireland Diagnostics Division

GUDID

200 records. Showing 1-40. Next