Identity
- Trade Name
- PartoSure test FDA PMA
- Generic Name
- Placental alpha microglobulin-1 immunoassay FDA PMA
Identifiers
- PMA Number
- P160052 FDA PMA
- FDA Product Code
- QBB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Clinical Toxicology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
PartoSure test by Qiagen, Inc. (placental alpha microglobulin-1 immunoassay) — Class III — FDA_PMA — listed in FDA PMA — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160052 | Class III | Active |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA PMA P160052 24 fields · synced Jun 18, 2026