SDP — Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit Class II
FDA product code SDP covers "Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit", a Class II medical device regulated under 21 CFR 864.1861. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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 |