Device |
kappa and lambda immunoglobulin light chain in situ hybridization mrna probe detection kit |
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 |
Product Code | SDP |
Regulation Number |
864.1861
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Device Class |
2
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