Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Bio-Rad Laboratories). ARTG record, intended purpose, GMDN…
- GMDN category: CT774 - Multiple-bacteria IVDs
Intended purpose
IVDs that are intended to be used in testing to provide information about infection with or exposure multiple specified bacterial organisms, detection of soluble antigens and identification of Neisseria Meningitidis A,C,Y/W135,B/E.coli K1, Haemophilus Influenzae B, Streptococcus Pneumoniae,Streptococcus B.