Product code PDS

Device name

Amniotic Fluid Protein Immunoassay

Medical specialty

Clinical Chemistry

Device class

1

Regulation number

862.1550

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

To detect specified amniotic fluid proteins in cervicovaginal samples

Source

FDA openFDA device classification dataset