Product code PJC

Device name

Newborn Screening Specimen Collection Paper

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

Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.

Source

FDA openFDA device classification dataset