Device typeOral/respiratory tract specimen container IVD, no additive/medium: An empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
FDA categoryDevice, specimen collection
Device ID00810044208139
Catalog number221-3996-G80
Single useYes
MRI safetyLabeling does not contain MRI Safety Information