Identity
- Trade Name
- Abbott RealTime IDH2 FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P170005 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Medical Genetics FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Abbott RealTime IDH2 by Abbott Molecular, Inc. (somatic gene mutation detection system) — 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 | P170005 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P170005 24 fields · synced Jun 18, 2026