Product code PJE

Device name

Blood/Plasma Collection Device For Dna Testing

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1675

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

Source

FDA openFDA device classification dataset