Identity
- Trade Name
- MAGE-A4 IHC 1F9 pharmDx FDA PMA
- Generic Name
- Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 FDA PMA
Identifiers
- PMA Number
- P230016 FDA PMA
- FDA Product Code
- SBL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 864.1860 FDA PMA
- Regulation Number
- 864.1860 FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
MAGE-A4 IHC 1F9 pharmDx by Agilent Technologies, Inc. (immunohistochemistry assay, antibody, melanoma-associated antigen a4) — Class III — FDA_PMA — listed in…
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 | P230016 | Class III | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA PMA P230016 24 fields · synced Jun 18, 2026