Intelligent bio solutions receives guidance from u.s. fda on a regulatory pathway for expansion into the united states for its intelligent fingerprinting drug screening cartridge

New york, june 28, 2023 (globe newswire) -- intelligent bio solutions inc. (nasdaq: inbs) (“inbs” or the “company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced it has received guidance from the u.s. food and drug administration (the “fda”) regarding the regulatory classification of its intelligent fingerprinting drug screening cartridge. the fda has provisionally determined that the cartridge falls within 21 cfr 862.3650, opiate test system, a class ii type device that requires the submission of a pre-market notification 510(k) and the fda's clearance prior to marketing.
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