QBB — Placental Alpha Microglobulin-1 Immunoassay Class III
FDA product code QBB covers "Placental Alpha Microglobulin-1 Immunoassay", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QBB
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Unknown
- Implant
- No
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.