Manufacturer's Devices - Meridian Bioscience Inc.

Address:




3471 River Hills Drive



Cincinnati

OH 45244

United States

Serilization:


Authorised Representative
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, rapidIVD General
Multiple faecal parasite antigen IVD, kit, fluorescent immunoassayIVD General
Mycoplasma pneumoniae nucleic acid IVD, controlIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD, controlIVD General
Beta-haemolytic Group A Streptococcus nucleic acid IVD, controlIVD General
Bordetella pertussis nucleic acid IVD, controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, controlIVD General
Multiple Plasmodium species nucleic acid IVD, controlIVD General
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)IVD General
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)IVD General
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)IVD General
Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)IVD General
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)IVD General
Rotavirus antigen IVD, kit, enzyme immunoassay (EIA)IVD General
Mycoplasma 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-testIVD General
Clostridium difficile antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Rotavirus antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Escherichia coli antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Multiple faecal parasite antigen IVD, controlIVD General
Multiple faecal parasite antigen IVD, kit, immunochromatographic test (ICT)IVD General
Multiple respiratory virus antigen IVD, controlIVD General
Respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Legionella pneumophila antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Streptococcus pneumoniae antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutinationIVD General
Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)IVD General
Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automatedIVD General
Fluorescent immunoassay analyser IVD, point-of-care, line-poweredIVD General
Helicobacter pylori antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
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)IVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD, controlIVD Annex II List B
Nucleic acid extraction/isolation kit IVDIVD Annex II List B
Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixativeIVD General
Faecal specimen container IVD, no additiveIVD General
Faecal specimen container IVD, transport buffer/mediumIVD General
Faecal parasite isolation kit IVDIVD General
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedIVD General
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)IVD General
General specimen collection kit IVDIVD General
Influenza A/B virus antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Nasopharyngeal aspirate container IVDIVD General
Helicobacter pylori antigen IVD, kit, fluorescent immunoassay, rapidIVD General
Clostridium difficile nucleic acid IVD, controlIVD General
Multiple gastrointestinal virus antigen IVD, kit, immunochromatographic test (ICT), rapidIVD General
Multiple gastrointestinal virus antigen IVD, controlIVD General