QMA

Blood Collection Device For Cell-Free Nucleic Acid

Product code

QMA

Device name

Blood Collection Device For Cell-Free Nucleic Acid

Device class

Class 2

21 CFR

21 CFR 862.1676

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-07-26.