Manufacturer's Devices - Meridian Bioscience Inc.

Address:




3471 River Hills Drive



Cincinnati

OH 45244

United States


Authorised Representative/ UK Responsible Person
Name: Launch Diagnostics Limited
Address:

Ash House Ash Road New Ash Green



Longfield

Kent DA3 8JD

United Kingdom




Code/Term Type
Cryptococcus neoformans antigen IVD kit agglutination rapidCryptococcus neoformans antigen IVD kit agglutination rapidIVD General
Multiple faecal parasite antigen IVD kit fluorescent immunoassayMultiple faecal parasite antigen IVD kit fluorescent immunoassayIVD General
Mycoplasma pneumoniae nucleic acid IVD controlMycoplasma pneumoniae nucleic acid IVD controlIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD controlBeta-haemolytic Group B Streptococcus nucleic acid IVD controlIVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD controlBeta-haemolytic Group A Streptococcus nucleic acid IVD controlIVD General
Bordetella pertussis nucleic acid IVD controlBordetella pertussis nucleic acid IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD controlHerpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD controlIVD General
Multiple Plasmodium species nucleic acid IVD controlMultiple Plasmodium species nucleic acid IVD controlIVD General
Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group A Streptococcus 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
Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group B Streptococcus 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
Bordetella pertussis nucleic acid IVD kit nucleic acid technique (NAT)Bordetella pertussis 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 Plasmodium species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Plasmodium species nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Helicobacter pylori antigen IVD kit enzyme immunoassay (EIA)Helicobacter pylori antigen IVD kit enzyme immunoassay (EIA)IVD General
Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Clostridium difficile antigen IVD kit enzyme immunoassay (EIA)Clostridium difficile antigen IVD kit enzyme immunoassay (EIA)IVD General
Rotavirus antigen IVD kit enzyme immunoassay (EIA)Rotavirus antigen IVD kit enzyme immunoassay (EIA)IVD General
Mycoplasma pneumoniae IgM antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testMycoplasma pneumoniae IgM antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testIVD General
Helicobacter pylori IgG antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testHelicobacter pylori IgG antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testIVD General
Clostridium difficile antigen IVD kit rapid ICT clinicalClostridium difficile antigen IVD kit rapid ICT clinicalIVD General
Rotavirus antigen IVD kit rapid ICT clinicalRotavirus antigen IVD kit rapid ICT clinicalIVD General
Escherichia coli antigen IVD kit rapid ICT clinicalEscherichia coli antigen IVD kit rapid ICT clinicalIVD General
Multiple faecal parasite antigen IVD controlMultiple faecal parasite antigen IVD controlIVD General
Multiple faecal parasite antigen IVD kit rapid ICT clinicalMultiple faecal parasite antigen IVD kit rapid ICT clinicalIVD General
Multiple respiratory virus antigen IVD controlMultiple respiratory virus antigen IVD controlIVD General
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalRespiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinicalIVD General
Legionella pneumophila antigen IVD kit rapid ICT clinicalLegionella pneumophila antigen IVD kit rapid ICT clinicalIVD General
Streptococcus pneumoniae antigen IVD kit rapid ICT clinicalStreptococcus pneumoniae antigen IVD kit rapid ICT clinicalIVD General
Epstein-Barr virus (EBV) heterophile antibody IVD kit agglutinationEpstein-Barr virus (EBV) heterophile antibody IVD kit agglutinationIVD General
Multiple antimicrobial resistance nucleic acid IVD kit nucleic acid technique (NAT)Multiple antimicrobial resistance nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Isothermal nucleic acid amplification analyser IVD laboratoryIsothermal nucleic acid amplification analyser IVD laboratoryIVD General
Fluorescent immunoassay analyser IVD point-of-care line-poweredFluorescent immunoassay analyser IVD point-of-care line-poweredIVD General
Helicobacter pylori antigen IVD kit rapid ICT clinicalHelicobacter pylori antigen IVD kit rapid ICT clinicalIVD General
Faecal specimen container IVD fixativeFaecal specimen container IVD fixativeIVD General
Faecal specimen container IVD no additiveFaecal specimen container IVD no additiveIVD General
Faecal specimen container IVD transport buffer/mediumFaecal specimen container IVD transport buffer/mediumIVD General
Faecal parasite isolation kit IVDFaecal parasite isolation kit IVDIVD General
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
General specimen collection kit IVD clinicalGeneral specimen collection kit IVD clinicalIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Nasopharyngeal aspirate container IVDNasopharyngeal aspirate container IVDIVD General
Helicobacter pylori antigen IVD kit fluorescent immunoassay rapidHelicobacter pylori antigen IVD kit fluorescent immunoassay rapidIVD General
Clostridium difficile nucleic acid IVD controlClostridium difficile nucleic acid IVD controlIVD General
Multiple gastrointestinal virus antigen IVD kit rapid ICT clinicalMultiple gastrointestinal virus antigen IVD kit rapid ICT clinicalIVD General
Multiple gastrointestinal virus antigen IVD controlMultiple gastrointestinal virus antigen IVD controlIVD General
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
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 controlCytomegalovirus (CMV) nucleic acid IVD controlIVD Annex II List B
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD Annex II List B
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDIVD General
Faecal specimen container IVD no additiveFaecal specimen container IVD no additiveClass A
Faecal specimen container IVD fixativeFaecal specimen container IVD fixativeClass A
Faecal specimen container IVD transport buffer/mediumFaecal specimen container IVD transport buffer/mediumClass A
Faecal parasite specimen concentration kit IVDFaecal parasite specimen concentration kit IVDClass A
Isothermal nucleic acid amplification analyser IVD laboratoryIsothermal nucleic acid amplification analyser IVD laboratoryClass A
Fluorescent immunoassay analyser IVD laboratory semi-automatedFluorescent immunoassay analyser IVD laboratory semi-automatedClass A
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryClass A