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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. Indications for Use 510 k Number if known Device Name illumigene Mycoplasma DNA Amplification Assay The illumigene Mycoplasma DNA amplification assay performed on the illumipro-10 is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs...

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