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SDPClass II

Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

21 CFR 864.1861 / Hematology
FDA source (opens on fda.gov)

SDP is the FDA product code for Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit, a class II device type, regulated under 21 CFR 864.1861. FDA's definition for this code reads: "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)...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SDP
Device name
Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
FDA 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
Regulation
21 CFR 864.1861
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SDP

By decision year
1 clearance under product code SDP with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDP by decision year
YearClearances
20241

Applicants with the most clearances

Product code SDP
Applicants holding the most 510(k) clearances under product code SDP
ApplicantClearances
Ventana Medical Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code