SDPClass II
Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Hematology · 21 CFR 864.1861
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
MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
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Event type breakdown
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code