Manufacturer's Devices - Abbott Ireland Diagnostics Division

Address:




Finisklin Business Park



Sligo

n/a

Ireland


Authorised Representative/ UK Responsible Person
Name: Abbott Laboratories Limited
Address:

Abbott House Vanwall Business Park Vanwall Road



Maidenhead

Berkshire SL64XE

England United Kingdom




Code/Term Type
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD calibratorCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD calibratorIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlCytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD controlCytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD controlIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD kit chemiluminescent immunoassayIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD calibratorCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD calibratorIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD controlCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Total prostate specific antigen (tPSA) IVD calibratorTotal prostate specific antigen (tPSA) IVD calibratorIVD Annex II List B
Total prostate specific antigen (tPSA) IVD controlTotal prostate specific antigen (tPSA) IVD controlIVD Annex II List B
Total prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayTotal prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD calibratorFree (unbound) prostate specific antigen (fPSA) IVD calibratorIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD controlFree (unbound) prostate specific antigen (fPSA) IVD controlIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayFree (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassayIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD calibratorRubella virus immunoglobulin G (IgG) antibody IVD calibratorIVD Annex II List B
Rubella virus immunoglobulin G (IgG) antibody IVD controlRubella virus immunoglobulin G (IgG) antibody IVD controlIVD Annex II List B
Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayRubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD calibratorRubella virus immunoglobulin M (IgM) antibody IVD calibratorIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD Annex II List B
Chemiluminescent immunoassay oxidizing reagent IVDChemiluminescent immunoassay oxidizing reagent IVDIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD calibratorSARS-CoV-2 immunoglobulin M (IgM) antibody IVD calibratorIVD General
Cyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayCyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassayIVD General
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorCyclosporin A/cyclosporine therapeutic drug monitoring IVD calibratorIVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassayThyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassayIVD General
Multiple thyroid antibody IVD controlMultiple thyroid antibody IVD controlIVD General
Multiple thyroid antibody IVD calibratorMultiple thyroid antibody IVD calibratorIVD General
Thyroglobulin antibody IVD kit chemiluminescent immunoassayThyroglobulin antibody IVD kit chemiluminescent immunoassayIVD General
Thyroglobulin antibody IVD controlThyroglobulin antibody IVD controlIVD General
Thyroglobulin antibody IVD calibratorThyroglobulin antibody IVD calibratorIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD controlSARS-CoV-2 immunoglobulin M (IgM) antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassayIVD General
Chemiluminescent immunoassay signal generation kit IVDChemiluminescent immunoassay signal generation kit IVDIVD General
Thyroid stimulating hormone receptor (TSHR) antibody IVD controlThyroid stimulating hormone receptor (TSHR) antibody IVD controlIVD General
Thyroid stimulating hormone receptor (TSHR) antibody IVD calibratorThyroid stimulating hormone receptor (TSHR) antibody IVD calibratorIVD General
Thyroid stimulating hormone receptor (TSHR) antibody IVD kit chemiluminescent immunoassayThyroid stimulating hormone receptor (TSHR) antibody IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 72-4 (CA 72-4) IVD kit chemiluminescent immunoassayCancer antigen 72-4 (CA 72-4) IVD kit chemiluminescent immunoassayIVD General
Cancer antigen 72-4 (CA72-4) IVD controlCancer antigen 72-4 (CA72-4) IVD controlIVD General
Cancer antigen 72-4 (CA72-4) IVD calibratorCancer antigen 72-4 (CA72-4) IVD calibratorIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassaySARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlSARS-CoV-2 immunoglobulin G (IgG) antibody IVD controlIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD calibratorSARS-CoV-2 immunoglobulin G (IgG) antibody IVD calibratorIVD General
Total cortisol IVD kit chemiluminescent immunoassayTotal cortisol IVD kit chemiluminescent immunoassayIVD General
Total cortisol IVD calibratorTotal cortisol IVD calibratorIVD General
Myoglobin IVD kit chemiluminescent immunoassayMyoglobin IVD kit chemiluminescent immunoassayIVD General
Myoglobin IVD controlMyoglobin IVD controlIVD General
Myoglobin IVD calibratorMyoglobin IVD calibratorIVD General
Wash/cleaning solution IVD automated/semi-automated systemWash/cleaning solution IVD automated/semi-automated systemIVD General
Procalcitonin (PCT) IVD kit chemiluminescent immunoassayProcalcitonin (PCT) IVD kit chemiluminescent immunoassayIVD General
Procalcitonin (PCT) IVD controlProcalcitonin (PCT) IVD controlIVD General
Procalcitonin (PCT) IVD calibratorProcalcitonin (PCT) IVD calibratorIVD General
Phosphate buffer/Sorenson buffer solution IVDPhosphate buffer/Sorenson buffer solution IVDIVD General
White blood cell count IVD kit cell countWhite blood cell count IVD kit cell countIVD General
Reticulocyte count IVD kit cell countReticulocyte count IVD kit cell countIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD calibratorCreatine kinase myocardial isoenzyme (CKMB) IVD calibratorIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD controlCreatine kinase myocardial isoenzyme (CKMB) IVD controlIVD General
Thyroid uptake (T-uptake) IVD kit chemiluminescent immunoassayThyroid uptake (T-uptake) IVD kit chemiluminescent immunoassayIVD General
Thyroid uptake (T-uptake) IVD controlThyroid uptake (T-uptake) IVD controlIVD General
Thyroid uptake (T-uptake) IVD calibratorThyroid uptake (T-uptake) IVD calibratorIVD General
Alpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayAlpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassayIVD General
Alpha-fetoprotein (AFP) IVD controlAlpha-fetoprotein (AFP) IVD controlIVD General
Alpha-fetoprotein (AFP) IVD calibratorAlpha-fetoprotein (AFP) IVD calibratorIVD General
Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayCarcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD controlCarcinoembryonic antigen (CEA) IVD controlIVD General
Carcinoembryonic antigen (CEA) IVD calibratorCarcinoembryonic antigen (CEA) IVD calibratorIVD General
Creatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassayCreatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassayIVD General
Blood cell lysis reagent IVDBlood cell lysis reagent IVDIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemIVD General
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayHerpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassayClass C
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD calibratorHerpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD calibratorClass C
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD controlHerpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD controlClass C
Hepatitis B virus surface antigen IVD calibratorHepatitis B virus surface antigen IVD calibratorIVD Annex II List A
Hepatitis B virus surface antigen IVD controlHepatitis B virus surface antigen IVD controlIVD Annex II List A
Hepatitis B virus surface antigen IVD kit chemiluminescent immunoassayHepatitis B virus surface antigen IVD kit chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus surface total antibody IVD calibratorHepatitis B virus surface total antibody IVD calibratorIVD Annex II List A
Hepatitis B virus surface total antibody IVD controlHepatitis B virus surface total antibody IVD controlIVD Annex II List A
Hepatitis B virus surface total antibody IVD kit chemiluminescent immunoassayHepatitis B virus surface total antibody IVD kit chemiluminescent immunoassayIVD Annex II List A
Rubella virus immunoglobulin M (IgM) antibody IVD controlRubella virus immunoglobulin M (IgM) antibody IVD controlIVD Annex II List B