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
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit Devices (Product Code SDP)

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

About Product Code SDP - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SDP since 2024, with 0 receiving FDA clearance (average review time: 190 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SDP devices are reviewed by the Pathology panel. Browse all Pathology devices →