Product code QUK
- Device name
- Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5960
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset