Blood Collection Device For Cell-Free Nucleic Acid
QMA · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1676
Classification
FDA Product Code
QMA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1676
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.