Device typeOral/respiratory tract specimen container IVD, additive/medium: A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] 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 (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
FDA categoryDna Specimen Collection, Saliva
Device ID00627595000255
AvailabilityPrescription or over the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information