In Vitro: ‘In Vitro’ means In an Artificial Environment, rather than inside a living organism, e.g. in a test tube.
In Vitro Diagnostic Medical Device: ‘In Vitro Diagnostic Medical Device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations , derived from the human body, solely or principally for the purpose of providing information.
In Vitro Diagnostic Use Only: To be used only for the purpose of identifying the use of a drug(s) or alcohol from a specimen gathered from a human body outside of a living organism i.e. a test tube.
For More Information:
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/
