Manufacturer's Devices - altona Diagnostics GmbH

Address:




altona Diagnostics GmbH Mörkenstr. 12



22767 Hamburg

22767

Germany


Authorised Representative/ UK Responsible Person
Name: altona diagnostics UK Ltd
Address:

No 1 St Pauls Square



Liverpool

L3 9SJ

England United Kingdom




Code/Term Type
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
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
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 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
Human herpesvirus 6 (HHV6) nucleic acid IVD kit nucleic acid technique (NAT)Human herpesvirus 6 (HHV6) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Adenovirus nucleic acid IVD kit nucleic acid technique (NAT)Adenovirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
JC virus (JCV) nucleic acid IVD kit nucleic acid technique (NAT)JC virus (JCV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT)Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT)IVD 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
Hepatitis A virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis A virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Adenovirus nucleic acid IVD reagentAdenovirus nucleic acid IVD reagentIVD General
Hepatitis E virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis E virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Human herpesvirus 6 (HHV6) nucleic acid IVD reagentHuman herpesvirus 6 (HHV6) nucleic acid IVD reagentIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD reagentHerpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD reagentIVD General
Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT)Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
JC virus (JCV) nucleic acid IVD reagentJC virus (JCV) nucleic acid IVD reagentIVD General
Norovirus nucleic acid IVD kit nucleic acid technique (NAT)Norovirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Parvovirus B19 nucleic acid IVD kit nucleic acid technique (NAT)Parvovirus B19 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
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
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDIVD General
Nucleic acid sample preparation instrument IVDNucleic acid sample preparation instrument IVDIVD General
Endogenous DNA/RNA internal control IVD kitEndogenous DNA/RNA internal control IVD kitIVD General
BK virus (BKV) nucleic acid IVD reagentBK virus (BKV) nucleic acid IVD reagentIVD General
Bordetella pertussis nucleic acid IVD kit nucleic acid technique (NAT)Bordetella pertussis nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Crimean-Congo haemorrhagic fever (CCHF) virus nucleic acid IVD kit nucleic acid technique (NAT)Crimean-Congo haemorrhagic fever (CCHF) virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Trypanosoma cruzi nucleic acid IVD kit nucleic acid technique (NAT)Trypanosoma cruzi nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Chikungunya virus nucleic acid IVD kit nucleic acid technique (NAT)Chikungunya virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Dengue virus nucleic acid IVD kit nucleic acid technique (NAT)Dengue virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Epstein-Barr virus (EBV) nucleic acid IVD reagentEpstein-Barr virus (EBV) nucleic acid IVD reagentIVD General
Escherichia coli nucleic acid IVD kit nucleic acid technique (NAT)Escherichia coli nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple enterovirus nucleic acid IVD kit nucleic acid technique (NAT)Multiple enterovirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple filovirus nucleic acid IVD kit nucleic acid technique (NAT)Multiple filovirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Hepatitis E virus nucleic acid IVD reagentHepatitis E virus nucleic acid IVD reagentIVD General
Human herpesvirus 6 (HHV6) antigen IVD reagentHuman herpesvirus 6 (HHV6) antigen IVD reagentIVD General
Human metapneumovirus (hMPV) nucleic acid IVD kit nucleic acid technique (NAT)Human metapneumovirus (hMPV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD reagentHerpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD reagentIVD General
Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD kit nucleic acid technique (NAT)Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
JC virus (JCV) antigen IVD reagentJC virus (JCV) antigen IVD reagentIVD General
Lassa virus nucleic acid IVD kit nucleic acid technique (NAT)Lassa virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Plasmodium malariae nucleic acid IVD kit nucleic acid technique (NAT)Plasmodium malariae nucleic acid IVD kit nucleic acid technique (NAT)IVD General
MERS-CoV nucleic acid IVD kit nucleic acid technique (NAT)MERS-CoV nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Norovirus nucleic acid IVD reagentNorovirus nucleic acid IVD reagentIVD General
Pneumocystis jirovecii nucleic acid IVD kit nucleic acid technique (NAT)Pneumocystis jirovecii nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Parvovirus B19 nucleic acid IVD reagentParvovirus B19 nucleic acid IVD reagentIVD General
Multiple human parainfluenza virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple human parainfluenza virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Rotavirus nucleic acid IVD kit nucleic acid technique (NAT)Rotavirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Respiratory syncytial virus (RSV) nucleic acid IVD kit nucleic acid technique (NAT)Respiratory syncytial virus (RSV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Rift Valley fever virus nucleic acid IVD kit nucleic acid technique (NAT)Rift Valley fever virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Varicella-zoster virus (VZV) nucleic acid IVD reagentVaricella-zoster virus (VZV) nucleic acid IVD reagentIVD General
West Nile virus nucleic acid IVD kit nucleic acid technique (NAT)West Nile virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Yellow fever virus nucleic acid IVD kit nucleic acid technique (NAT)Yellow fever virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Zika virus nucleic acid IVD kit nucleic acid technique (NAT)Zika virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Adenovirus antigen IVD reagentAdenovirus antigen IVD reagentIVD General
Hepatitis A virus nucleic acid IVD reagentHepatitis A virus nucleic acid IVD reagentIVD 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
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A