PJE

Blood/Plasma Collection Device For Dna Testing

Product code: PJE
Device name: Blood/Plasma Collection Device For Dna Testing
Device class: Class 2
21 CFR: 21 CFR 862.1675
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 8 (all years; only the last 3 years are listed here)

FDA classification definition

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

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

Official FDA classification page: PJE

Classification and pathway per current FDA publications. Data from openFDA (CC0).