Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
QUK · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5960
Classification
FDA Product Code
QUK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5960
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.