SDP · Class II · 21 CFR 864.1861

FDA Product Code SDP: Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

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

Leading manufacturers include Ventana Medical Systems, Inc..

1
Total
0
Cleared
190d
Avg days
2024
Since

List of Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit devices cleared through 510(k)

1 devices
1–1 of 1
Not Cleared Dec 05, 2024
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
DEN240025
Ventana Medical Systems, Inc.
Pathology · 190d

How to use this database

This page lists all FDA 510(k) submissions for Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit devices (product code SDP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Pathology FDA review panel. Browse all Pathology devices →