Device typeOral/upper respiratory tract specimen collection kit IVD, clinical: A collection of devices intended exclusively for professional use to assist in the extraction/collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. The kit consists of a non-suctioning specimen sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle/container(s) with or without an additive/medium [e.g., pre-rinse/irrigation solution, tartrazine colouring agent, transport microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
FDA categoryOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
Device ID10850009370225
Catalog number12-0610-01
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information