Federal Register Notice: FDA is making available a guidance, Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions. The agency is clarifying the regulations on commercially distributed ASRs and the role and responsibilities of ASR manufacturers. Manufacturers should ensure their Class 2 or Class 3 in vitro diagnostic devices that are currently inappropriately labeled and marketed as ASRs come into compliance with the law by 9/15/08. To download this guidance, click here. To view this notice, click here.