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therascreen BRAF V600E RGQ PCR Kit
FDA PMAClass III (US FDA PMA)
PMA P190026
by QIAGEN GmbH
Identity
- Trade Name
- therascreen BRAF V600E RGQ PCR Kit FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P190026 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
therascreen BRAF V600E RGQ PCR Kit by QIAGEN GmbH (somatic gene mutation detection system) — Class III — FDA_PMA — listed in FDA PMA
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 | P190026 | Class III | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
Sources (1)
- FDA PMA P190026 24 fields · synced Jun 18, 2026