Blood Collection Device For Cell-Free Nucleic Acid
Medical specialty
Clinical Chemistry
Device class
2
Regulation number
862.1676
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.