At KML, we have two methods that we use to identify cultures. The first being our primary practice of identification, which is through the use of PCR sequencing to create copies of the DNA strands and identify the findings. Our PCR sequencing method has the potential to detect microbial species by the amplification of gene sequences that are unique to that organism. Our second practice of microbial identification is through the use of our VITEK 2 Compact system. The VITEK2 is used to provide reliable and accurate results for clinically important gram-positive cocci, gram-negative bacilli rods, and yeasts.
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We’ve worked closely with the FDA for years. Please allow us to better explain what tests and test methods may be required to be performed by the FDA. We are here to assist you in as many ways that we can. Our staff is friendly and always happy to help.