Identity
- Trade Name
- VYSIS CLL FISH PROBE KIT FDA PMA
- Generic Name
- Fluorescence in situ hybridization, chromosome 17p deletion (TP53) FDA PMA
Identifiers
- PMA Number
- P150041 FDA PMA
- FDA Product Code
- PNK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Vysis CLL FISH Probe Kit by Abbott Molecular, Inc. (fluorescence in situ hybridization, chromosome 17p deletion (tp53)) — Class III — FDA_PMA — listed in FDA…
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 | P150041 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P150041 24 fields · synced Jun 18, 2026