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QUK — Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test Class II

FDA Device Classification

FDA product code QUK covers "Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test", a Class II medical device regulated under 21 CFR 866.5960. Submissions are reviewed by the Immunology panel.

Classification Details

Product Code
QUK
Device Class
Class II
Regulation Number
866.5960
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

A Human Leukocyte Antigen (HLA) Typing Companion Diagnostic (CDx) Test is a prescription genotyping or phenotyping assay intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product, or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product.

FDA data resources