Infectech Registers Identikit Test Kits With FDA

Infectech has received notification from the FDA's Center for Devices and Radiological Health of registration of the company and its initial product line for biophasic system devices.

Infectech's Identikit product line was developed for the rapid identification and antibiotic testing of disease-causing pathogens. 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, Paratuberculosis, as well as Pseudomonas and Nocardia species. These bacteria are cited as prominent causes of morbidity and mortality in patients with cancer, cystic fibrosis and AIDS.

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.