SDP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1861
- Medical specialty
- Hematology
- FDA 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
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| Record | Firm | Date |
|---|---|---|
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
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