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Intelligent Bio Solutions Inc. files FDA 513(g) regulatory submission for Intelligent Fingerprinting Drug Screening Cartridge
- 513(g) submission will allow Intelligent Bio Solutions Inc. to determine the most suitable FDA regulatory pathway for its Intelligent Fingerprinting Drug
About this update from Intelligent Bio Solutions Inc.
[{"type":"text","content":"- 513(g) submission will allow Intelligent Bio Solutions Inc. to determine the most suitable FDA regulatory pathway for its Intelligent Fingerprinting Drug Screening Cartridge, as the next step in its expansion strategy into the U.S. - - Intelligent Fingerprinting Drug Screening Cartridge quickly detects the presence of four drugs and/or their metabolites from fingerprint sweat - NEW YORK, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (\"Intelligent Bio Solutions\" or the \"Company\") (Nasdaq: INBS), a life sciences company developing and delivering intelligent, non-invasive, real-time testing solutions, today announced that the Company has filed a 513(g) submission with the United States Food and Drug Administration (FDA) for its Intelligent Fingerprinting Drug Screening Cartridge. The submission will allow Intelligent Bio Solutions to determine the most suitable FDA regulatory pathway as part of the Company’s strategy for expansion into the U.S. market. \"This is a significant step that marks the commencement of our expansion into the United States,\" said Harry Simeonidis, Chief Executive Officer at Intelligent Bio Solutions. \"Our goal is to help address the increasing tide of drug abuse challenges by providing a proven, non-invasive, affordable and easy-to-use product that facilitates the broader adoption of drug screening, thereby promoting a safer work environment.\" The Intelligent Fingerprinting Drug Screening test detects the presence of four drugs and/or their metabolites from fingerprint sweat. The drug testing system features a small, tamper-evident drug screening cartridge onto which ten fingerprint sweat samples are collected in a process that takes less than a minute. The rapid test detects combinations of opiates, methamphetamine, cocaine, and the active ingredient in cannabis: delta-9-tetrahydrocannabinol (THC), in under ten minutes. About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. is a life sciences company developing and delivering intelligent, non-invasive, real-time testing solutions to customers globally. With its world-first biosensor platform, Intelligent Bio Solutions is developing and launching diagnostic tests urgently needed to help people living with chronic disease. In addition, through its recent acquisition of Intelligent Fingerprinting Limited, the Company i...