Perfectus Biomed support companies with their data generation portfolio in order to support their 510(k) submission.The FDA require 510(k) premarket submissions for new devices that are not subject to Post Market Approval (PMA). The submission demonstrates that a device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)). Submitters must compare their device to one or more similar legally marketed devices. When a 510(K) submission is required:
- When commercial distribution of a new device is occurring for the first time.
- When there is a change/modification to an existing legally marketed device that may affect its safety or effectiveness.
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 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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We are happy to help with your microbiological requirements and with any other queries you may have.