Definition: Commercially prepared reagent sets, with accessory devices, containing all of the major components and literature necessary to perform one or more designated diagnostic tests or procedures. They may be for laboratory or personal use.
Other names Diagnostic Reagent Kits; Test Kits, Diagnostic; Test Kit, Diagnostic; Reagent Kit, Diagnostic; Kits, Diagnostic Test; Kit, Diagnostic Test; Kit, Diagnostic Reagent; Diagnostic Test Kit; Diagnostic Reagent Kit; Kits, Diagnostic Reagent; In Vitro Diagnostic Medical Devices; In Vitro Diagnostic Medical Device; In Vitro Diagnostic Devices; In Vitro Diagnostic Device; Diagnostic Test Kits; Diagnostic Reagents and Test Kits