FDA product code QUK: Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
QUK is the FDA product code for human leukocyte antigen (hla) typing companion diagnostic test. It is a Class II device, regulated under 21 CFR 866.5960 and reviewed by the Immunology panel. Devices under QUK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test |
| Device class | Class II |
| Regulation | 21 CFR 866.5960 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Recalls for QUK devices
openFDA lists no recalls for product code QUK.
Frequently asked questions
What is FDA product code QUK?
QUK is the FDA product code for human leukocyte antigen (hla) typing companion diagnostic test. It is a Class II device, regulated under 21 CFR 866.5960 and reviewed by the Immunology panel.
What device class is QUK?
Class II, regulation 21 CFR 866.5960. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUK
- Run a recall and safety report across every QUK manufacturer
- Watch product code QUK 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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