QBB

Placental Alpha Microglobulin-1 Immunoassay

Product code: QBB
Device name: Placental Alpha Microglobulin-1 Immunoassay
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.

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

Official FDA classification page: QBB

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