Device typeEndocervical specimen cytological examination kit IVD: A collection of noninvasive in vitro diagnostic devices intended to be used in the clinical laboratory for the preparation, processing, and microscopic examination of an endocervical cytological specimen previously collected from a patient, typically as part of a woman's regular pelvic examination and cervical cancer screening. It may be referred to as Papanicolaou (Pap) smear test and typically consists of specimen suspension homogenization reagents and preservatives, cytological centrifuge funnels, fixative/stain solutions, and microscopy slides. This is a single-use device.
FDA categoryProcessor, cervical cytology slide, automated
Device ID00382904914547
Catalog number491454
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information