QUKClass II

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

21 CFR 866.5960 / Immunology

QUK is the FDA product code for Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test, a class II device type, regulated under 21 CFR 866.5960. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QUK
Device name: Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
FDA 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.
Regulation: 21 CFR 866.5960
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

One Lambda, Inc

Recent clearances

Product code QUK

FDA records hold no clearances under product code QUK.

Recent recalls

Product code QUK

FDA records show no recalls under product code QUK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)