Product code QSA

Device name

Circulating Tumor Cell (Ctc) Enrichment Device

Medical specialty

Immunology

Device class

2

Regulation number

866.6110

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.

Source

FDA openFDA device classification dataset