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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. GUY SEVIGNY SENIOR REGULATORY AFFAIRS SPECIALIST 360 RUE FRANQUET QUEBEC G1P 4N3 CA Re K170558 Trade/Device Name Revogene Regulation Number 21 CFR 862. Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR. Type of Use Select one or both as applicable...
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