Manufacturer's Devices - Abbott Molecular Inc.

Address:




1350 E. Touhy Ave



Des Plaines IL

Illinois 60018

United States


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
Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
Hepatitis C virus nucleic acid IVD controlHepatitis C virus nucleic acid IVD controlIVD Annex II List A
Hepatitis C virus nucleic acid IVD calibratorHepatitis C virus nucleic acid IVD calibratorIVD Annex II List A
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1 nucleic acid IVD controlHIV1 nucleic acid IVD controlIVD Annex II List A
HIV1 nucleic acid IVD calibratorHIV1 nucleic acid IVD calibratorIVD Annex II List A
Nucleic acid sequencing reagent kit IVDNucleic acid sequencing reagent kit IVDIVD Annex II List A
Hepatitis C virus genotyping IVD kit nucleic acid technique (NAT)Hepatitis C virus genotyping IVD kit nucleic acid technique (NAT)IVD Annex II List A
Hepatitis C virus genotyping IVD controlHepatitis C virus genotyping IVD controlIVD Annex II List A
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD controlMultiple-type sexually transmitted pathogen nucleic acid IVD controlIVD Annex II List B
Multiple congenital aneuploidy screening IVD controlMultiple congenital aneuploidy screening IVD controlIVD Annex II List B
Multiple congenital aneuploidy screening IVD probeMultiple congenital aneuploidy screening IVD probeIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD calibratorCytomegalovirus (CMV) nucleic acid IVD calibratorIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD controlCytomegalovirus (CMV) nucleic acid IVD controlIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple congenital aneuploidy screening IVD probeMultiple congenital aneuploidy screening IVD probeIVD General
Tissue processor IVD automatedTissue processor IVD automatedIVD General
C-erbB2/Her2/neu oncoprotein IVD controlC-erbB2/Her2/neu oncoprotein IVD controlIVD General
T-cell acute lymphoblastic leukaemia (T-ALL) genetic mutation IVD probeT-cell acute lymphoblastic leukaemia (T-ALL) genetic mutation IVD probeIVD General
Acute promyelocytic leukaemia (APL) genetic mutation IVD probeAcute promyelocytic leukaemia (APL) genetic mutation IVD probeIVD General
B-cell malignancy IVD kit nucleic acid technique (NAT)B-cell malignancy IVD kit nucleic acid technique (NAT)IVD General
Nucleic acid hybridization detection IVD kitNucleic acid hybridization detection IVD kitIVD General
Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT)Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT)IVD General
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD probeChronic lymphocytic leukaemia (CLL) genetic mutation IVD probeIVD General
Idiopathic hypereosinophilic syndrome/chronic eosinophilic leukaemia IVD probeIdiopathic hypereosinophilic syndrome/chronic eosinophilic leukaemia IVD probeIVD General
Prader-Willi syndrome IVD probePrader-Willi syndrome IVD probeIVD General
William-Beuren syndrome IVD probeWilliam-Beuren syndrome IVD probeIVD General
Cancer/tumour-associated aneuploidy IVD probeCancer/tumour-associated aneuploidy IVD probeIVD General
Multiple myeloma genetic mutation IVD probeMultiple myeloma genetic mutation IVD probeIVD General
Oligodendroglioma loss of heterozygosity (LOH) IVD probeOligodendroglioma loss of heterozygosity (LOH) IVD probeIVD General
Bladder tumour-associated mutation IVD probeBladder tumour-associated mutation IVD probeIVD General
Bladder tumour-associated mutation IVD controlBladder tumour-associated mutation IVD controlIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General
Nucleic acid hybridization detection IVD probeNucleic acid hybridization detection IVD probeIVD General
Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
DAPI solution IVDDAPI solution IVDIVD General
PCR instrument calibrator kit IVDPCR instrument calibrator kit IVDIVD General
Cyclin D1 genetic mutation IVD probeCyclin D1 genetic mutation IVD probeIVD General
Phosphatase and tensin homolog (PTEN) gene IVD probePhosphatase and tensin homolog (PTEN) gene IVD probeIVD General
Myelodysplastic syndrome (MDS) IVD probeMyelodysplastic syndrome (MDS) IVD probeIVD General
SRY gene sex-determination IVD probeSRY gene sex-determination IVD probeIVD General
Anaplastic lymphoma kinase (ALK) genetic mutation IVD controlAnaplastic lymphoma kinase (ALK) genetic mutation IVD controlIVD General
Molecular grade lysis reagent IVDMolecular grade lysis reagent IVDIVD General
Assay container IVD single-useAssay container IVD single-useIVD General
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDIVD General
Thermal cycler nucleic acid amplification analyser IVD laboratory automatedThermal cycler nucleic acid amplification analyser IVD laboratory automatedIVD General
Molecular grade buffered sample diluent IVDMolecular grade buffered sample diluent IVDIVD General
Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Human papillomavirus (HPV) high-risk strain nucleic acid IVD controlHuman papillomavirus (HPV) high-risk strain nucleic acid IVD controlIVD General
Cytology specimen container IVD transport bufferCytology specimen container IVD transport bufferIVD General
Epstein-Barr virus (EBV) nucleic acid IVD controlEpstein-Barr virus (EBV) nucleic acid IVD controlIVD General
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
Molecular grade alcohol IVDMolecular grade alcohol IVDIVD General
Molecular grade procedure oil IVDMolecular grade procedure oil IVDIVD General
C-erbB2/Her2/neu oncoprotein IVD reagentC-erbB2/Her2/neu oncoprotein IVD reagentIVD General
Anaplastic lymphoma kinase (ALK) genetic mutation IVD probeAnaplastic lymphoma kinase (ALK) genetic mutation IVD probeIVD General
Philadelphia chromosome/BCR-ABL transcript IVD probePhiladelphia chromosome/BCR-ABL transcript IVD probeIVD General
DiGeorge syndrome IVD probeDiGeorge syndrome IVD probeIVD General
B-cell malignancy IVD reagentB-cell malignancy IVD reagentIVD General
B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD probeB-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD probeIVD General
Acute myeloid leukaemia (AML) genetic mutation IVD probeAcute myeloid leukaemia (AML) genetic mutation IVD probeIVD General
ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD kit nucleic acid technique (NAT)ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD kit nucleic acid technique (NAT)IVD General
Nucleic acid hybridization detection IVD reagentNucleic acid hybridization detection IVD reagentIVD General
Laboratory waste receptacle IVDLaboratory waste receptacle IVDIVD General
Nucleic acid sample preparation instrument IVD automatedNucleic acid sample preparation instrument IVD automatedIVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General
Epstein-Barr virus (EBV) nucleic acid IVD calibratorEpstein-Barr virus (EBV) nucleic acid IVD calibratorIVD General
Instrument/analyser test tube rack holder IVDInstrument/analyser test tube rack holder IVDIVD General
Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus nucleic acid IVD controlHepatitis B virus nucleic acid IVD control Conformity Assessment Certificate ExpiredIVD Annex II List A
Hepatitis B virus nucleic acid IVD calibratorHepatitis B virus nucleic acid IVD calibrator Conformity Assessment Certificate ExpiredIVD Annex II List A
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)IVD General