Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
The Human Leukocyte Antigen (HLA) Typing Companion Diagnostic Test is a prescription genotyping or phenotyping assay intended as an aid in identifying patients with specific HLA alleles or antigens who may benefit from a particular therapeutic product or who may be at increased risk for serious adverse reactions to a corresponding therapeutic product. HLA typing is critical for pharmacogenomic decision-making in drug therapy and organ transplantation. Classified as FDA Class 2 under regulation 866.5960, it requires 510(k) clearance in the Immunology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QUK
- Device Class
- FDA class 2
- Regulation Number
- 866.5960
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.