510(k) submission support
510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Perfectus Biomed support companies with their data generation portfolio in order to support their 510(k) submission.
Our library of test organism includes…
Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.
Single or mixed species assays containing:
Acinetobacter baumannii, Actinomyces naeslundii, Adenovirus (human), Aspergillus brasiliensis, Aspergillums niger, Aureobasidium pullulans, Bacillus cereus, Bacillus subtilis, Camplylobacter jejuni, Candida albicans, Clostridium difficile, Corynebacterium minutissimum, Enterobacter cloacae, Enterococcus faecalis, Enterococcus faecium (VRE), Enterococcus hirae, Escherichia coli, Fusobacterium nucleatum, Haemophilus influenzae, Heliocbacter pylori, Halomonas magadiensis, Klebsiella pneumoniae, Lactobacillus casei, MRSA, Neisseria gonorrhoeae, Neisseria subflava, Porphyromonas ginigvalis, Prevotella nigrescens, Propionibacterium acnes, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella enteritidis, Shigella dysenteriae, Staphylococcus aureus (MRSA and MSSA), Staphylococcus epidermidis, Staphylococcus haemolyticus, Stenotrophomonas maltophilia, Streptococcus mutans, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus zooepidemicus, Tannerella forsythia, Trichophyton rubrum, Veillonella dispar. WHO Priority organisms. Other- please ask.
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