QBB · Placental Alpha Microglobulin-1 Immunoassay
· Class 3
Overview
| Product Code | QBB |
|---|---|
| Device Name | Placental Alpha Microglobulin-1 Immunoassay |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160052 | PartoSure test | Qiagen, Inc. | Apr 11, 2018 | APPR |
Top Applicants
- Qiagen, Inc. — 1 clearance
