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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. AUSTIN TX 78727 December 23 2016 Re K162772 Trade/Device Name ARIES GBS Assay Regulation Number 21 CFR 866. 510 k Number if known Device Name ARIES GBS Assay qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus GBS nucleic acid from 18-24 hour Lim broth enrichments of...
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