510(k) DEN240025

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) by Ventana Medical Systems, Inc. — Product Code SDP

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 5, 2024
Date Received: May 29, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Device Class: Class II
Regulation Number: 864.1861
Review Panel: MG
Submission Type

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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