QUK
- Product code
- QUK
- Device name
- Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5960
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
FDA classification 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.
Official FDA classification page: QUK
Classification and pathway per current FDA publications. Data from openFDA (CC0).