OYJ

Dna Specimen Collection, Saliva

Product code

OYJ

Device name

Dna Specimen Collection, Saliva

Device class

Class 2

21 CFR

21 CFR 862.1675

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.

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