Manufacturer's Devices - GeneProof a.s.

Address:




101/119 Dolní Heršpice

Vídeská Brno

Brno-msto

Jihomoravský kraj 619 00

Czechia


Authorised Representative/ UK Responsible Person
Name: Pathway Diagnostics Ltd
Address:

Eclipse House Curtis Road



Dorking

Surrey RH4 1EJ

United Kingdom




Code/Term Type
Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1 genotyping IVD kit nucleic acid technique (NAT)HIV1 genotyping IVD kit nucleic acid technique (NAT)IVD Annex II List A
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
Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Chlamydia pneumoniae nucleic acid IVD kit nucleic acid technique (NAT)Chlamydia pneumoniae 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
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
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
Multiple immunocompromised host infection-associated virus nucleic acid IVD nucleic acid technique (NAT)Multiple immunocompromised host infection-associated virus nucleic acid IVD 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
Aspergillus fumigatus nucleic acid IVD kit nucleic acid technique (NAT)Aspergillus fumigatus 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
Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT)Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Human herpesvirus 8 (HHV8) nucleic acid IVD kit nucleic acid technique (NAT)Human herpesvirus 8 (HHV8) 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
Varicella-zoster virus (VZV) nucleic acid IVD kit nucleic acid technique (NAT)Varicella-zoster virus (VZV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT)Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT)IVD General
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 General
Multiple Mycoplasma species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Mycoplasma species nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Ureaplasma urealyticum nucleic acid IVD kit nucleic acid technique (NAT)Ureaplasma urealyticum nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Trichomonas vaginalis nucleic acid IVD kit nucleic acid technique (NAT)Trichomonas vaginalis nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Treponema pallidum nucleic acid IVD kit nucleic acid technique (NAT)Treponema pallidum nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Borrelia burgdorferi nucleic acid IVD kit nucleic acid technique (NAT)Borrelia burgdorferi nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Enterovirus nucleic acid (serotypes 68-71) IVD kit nucleic acid technique (NAT)Enterovirus nucleic acid (serotypes 68-71) IVD kit nucleic acid technique (NAT)IVD General
MRSA nucleic acid IVD kit nucleic acid technique (NAT)MRSA nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD kit nucleic acid technique (NAT)Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD kit nucleic acid technique (NAT)IVD 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
Multiple Bordetella species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Bordetella species nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Legionella pneumophila nucleic acid IVD kit nucleic acid technique (NAT)Legionella pneumophila nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Mycoplasma pneumoniae nucleic acid IVD kit nucleic acid technique (NAT)Mycoplasma pneumoniae nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT)Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Coagulation factor II (prothrombin) mutation IVD kit nucleic acid technique (NAT)Coagulation factor II (prothrombin) mutation IVD kit nucleic acid technique (NAT)IVD General
Inherited thrombophilia IVD kit nucleic acid technique (NAT)Inherited thrombophilia IVD kit nucleic acid technique (NAT)IVD General
Coagulation factor XIII mutation IVD kit nucleic acid technique (NAT)Coagulation factor XIII mutation IVD kit nucleic acid technique (NAT)IVD General
Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT)Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT)IVD General
Cardiovascular disease genetic risk IVD kit nucleic acid technique (NAT)Cardiovascular disease genetic risk IVD kit nucleic acid technique (NAT)IVD General
Plasminogen activator inhibitor 1 (PAI-1) mutation IVD kit nucleic acid technique (NAT)Plasminogen activator inhibitor 1 (PAI-1) mutation IVD kit nucleic acid technique (NAT)IVD General
PCR/NAT negative control IVDPCR/NAT negative control IVDIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General