FDA product code SDP: Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

SDP is the FDA product code for kappa and lambda immunoglobulin light chain in situ hybridization mrna probe detection kit. It is a Class II device, regulated under 21 CFR 864.1861 and reviewed by the Medical Genetics panel. Devices under SDP reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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

Classification

Recalls for SDP devices

openFDA lists no recalls for product code SDP.

Frequently asked questions

What is FDA product code SDP?

SDP is the FDA product code for kappa and lambda immunoglobulin light chain in situ hybridization mrna probe detection kit. It is a Class II device, regulated under 21 CFR 864.1861 and reviewed by the Medical Genetics panel.

What device class is SDP?

Class II, regulation 21 CFR 864.1861. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SDP
• Run a recall and safety report across every SDP manufacturer
• Watch product code SDP for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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