Manufacturer's Devices - NeuMoDx Molecular

Address:




1250 Eisenhower Pl Ann Arbor



Washtenaw

MI 48108-3281

United States


Authorised Representative/ UK Responsible Person
Name: QIAGEN Manchester Ltd.
Address:

QIAGEN Manchester Ltd. Citylabs 2.0

200 Hathersage Road

Manchester

M13 0BH

England United Kingdom




Code/Term Type
Cytomegalovirus (CMV) nucleic acid IVD controlCytomegalovirus (CMV) nucleic acid IVD controlIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD calibratorCytomegalovirus (CMV) nucleic acid IVD calibratorIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD reagentCytomegalovirus (CMV) nucleic acid IVD reagentIVD Annex II List B
Molecular grade lysis reagent IVDMolecular grade lysis reagent IVDIVD General
Assay development analyte-specific reagent IVDAssay development analyte-specific reagent IVDIVD 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
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Microplate IVDMicroplate IVDIVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD reagentMultiple-type sexually transmitted pathogen nucleic acid IVD reagentIVD General
Human papillomavirus (HPV) nucleic acid IVD reagentHuman papillomavirus (HPV) nucleic acid IVD reagentIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD reagentBeta-haemolytic Group B Streptococcus nucleic acid IVD reagentIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
Oral/upper respiratory tract specimen collection kit IVD clinicalOral/upper respiratory tract specimen collection kit IVD clinicalIVD General
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemIVD General
Molecular grade buffered sample diluent IVDMolecular grade buffered sample diluent IVDIVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD reagentMultiple-type sexually transmitted pathogen nucleic acid IVD reagentIVD Annex II List B
Hepatitis B virus nucleic acid IVD calibratorHepatitis B virus nucleic acid IVD calibratorIVD Annex II List A
Hepatitis B virus nucleic acid IVD controlHepatitis B virus nucleic acid IVD controlIVD Annex II List A
Hepatitis B virus nucleic acid IVD reagentHepatitis B virus nucleic acid IVD reagentIVD Annex II List A
Hepatitis C virus nucleic acid IVD calibratorHepatitis C virus nucleic acid IVD calibratorIVD 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 reagentHepatitis C virus nucleic acid IVD reagentIVD Annex II List A
HIV1 nucleic acid IVD calibratorHIV1 nucleic acid IVD calibratorIVD Annex II List A
HIV1 nucleic acid IVD controlHIV1 nucleic acid IVD controlIVD Annex II List A
HIV1 nucleic acid IVD reagentHIV1 nucleic acid IVD reagentIVD Annex II List A
Laboratory waste receptacle IVDLaboratory waste receptacle IVDIVD General
Molecular grade lysis reagent IVDMolecular grade lysis reagent IVDClass A
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemClass A
Molecular grade buffered sample diluent IVDMolecular grade buffered sample diluent IVDClass A
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryClass A
Laboratory waste receptacle IVDLaboratory waste receptacle IVDClass A
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDClass A
Assay development analyte-specific reagent IVDAssay development analyte-specific reagent IVDClass A
Microplate IVDMicroplate IVDClass A
Epstein-Barr virus (EBV) nucleic acid IVD reagentEpstein-Barr virus (EBV) nucleic acid IVD reagentIVD General
Epstein-Barr virus (EBV) nucleic acid IVD calibratorEpstein-Barr virus (EBV) nucleic acid IVD calibratorIVD General
Epstein-Barr virus (EBV) nucleic acid IVD controlEpstein-Barr virus (EBV) nucleic acid IVD controlIVD General
Multiple respiratory virus nucleic acid IVD reagentMultiple respiratory virus nucleic acid IVD reagentIVD General
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General