SDP — Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit Class II
Classification Details
- Product Code
- SDP
- Device Class
- Class II
- Regulation Number
- 864.1861
- Submission Type
- Review Panel
- MG
- Medical Specialty
- Hematology
- Implant
- No
Definition
A kappa and lambda immunoglobulin light chain in situ hybridization (ISH) mRNA probe is intended as an aid in the identification of hematolymphoid neoplasms using in situ hybridization. A Kappa and Lambda ISH mRNA probe cocktail is indicated for use when a hematolymphoid biopsy (e.g., bone marrow, lymphoid tissue) yields inconclusive results. The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240025 | ventana medical systems | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | December 5, 2024 |