DeviceClearance

Product code SDP— Hematology

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

Classification name
Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Device class
Class 2
Regulation
21 CFR 864.1861
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code SDP under 21 CFR 864.1861, via openFDA

Market context for product code SDP

FDA has cleared 1 device under product code SDP, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SDP

Recent clearances under product code SDP

Data sourced from openFDA. This site is unofficial and independent of the FDA.