SDP · Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Hematology · 21 CFR 864.1861 · Class 2
Overview
| Product Code | SDP |
|---|---|
| Device Name | Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit |
| Regulation | 21 CFR 864.1861 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is a qualitative mRNA reagent designed to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens (lymph node and bone marrow) by in situ hybridization (ISH). It is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms, specifically when a biopsy indicates inconclusive results, by enabling the assessment of both markers on a single slide to differentiate between a reactive process or B-cell lymphoma and plasma cell neoplasms.
Classification Rationale
Class II (special controls). The device is classified under 21 CFR 864.1861 as a hematolymphoid neoplasm immunoglobulin mRNA in situ hybridization detection device.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Ventana Medical Systems, Inc. | Dec 5, 2024 | DENG |
Top Applicants
- Ventana Medical Systems, Inc. — 1 clearance
