Infectech Registers Identikit Test Kits With FDA
Infectech, Inc. have announced it has received notification from the FDA, of registration of the company and its initial product line for biophasic system devices.
Because it was categorized as a medical device that did not require the standard lengthy FDA approval process, Infectech intends to begin the production, marketing and commercializing of its biophasic system devices to cultivate and identify certain pathogenic microorganisms for medical purposes.
Infectech's Indentikit product line was developed for the rapid identification and antibiotic testing of disease-causing pathogens. The basic test kit consists of a glass slide coated with paraffin, which is used as a carbon (food) source by certain bacterial species. The slides are incubated in a sample of almost any bodily fluid (a non-invasive sample of saliva is preferred) within a nutrient broth. This creates a semi-solid growth medium for the bacteria, which imitates its natural environment within a human or animal host. The bacteria collect on the paraffin slide in 4-8 days.
Testing can then be done to identify the species of bacteria. This testing can be done via acid-fast staining or through PCR gene amplification. Additionally, the bacteria can be cultured with antibiotics to test for specific sensitivities.
Through the choice of different nutrient broths, each kit can be tailored to encourage the growth of a specific bacterium. The test kits are being designed to work on a class of bacteria that includes Mycobacterium Tuberculosis, Mycobacterium avium complex (MAC), Paratuberculosis, as well as Pseudomonas and Nocardia species.
Source : Infectech, Inc. View Company Information
Posted on February 10, 2005