Microprobe
This article was originally published in The Gray Sheet
Executive Summary
FDA grants firm permission to export its Affirm DP microbial identification test system to 11 countries. Intended for use in dental offices, the test is the first DNA-probe product for detecting and distinguishing between microorganisms associated with periodontal disease, Microprobe says. The firm, which has not yet filed for FDA clearance for U.S. marketing of the product, plans to begin overseas shipments during the first quarter. Microprobe received clearance for its Affirm VP vaginitis test in September ("The Gray Sheet" Oct. 5, p. 16)....