FDA Product Code QVU: High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
A High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System Is A Qualitative In Vitro Diagnostic (ivd) System Intended For Analysis Of Human Dna Extracted From Human Specimens To Detect Germline Mutations In A Panel Of Targeted Cancer Related Genes. It Is Intended To Aid In Hereditary Cancer Predisposition Assessment By Qualified Health Care Professionals In Accordance With Professional Guidelines. The Device Is Not Intended For Screening, Prenatal Testing Or As A Stand-alone Diagnostic Test. The Device Is For Prescription Use Only.
Leading manufacturers include Invitae Corporation.
FDA 510(k) Cleared High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. Devices (Product Code QVU)
About Product Code QVU - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QVU since 2023, with 0 receiving FDA clearance (average review time: 914 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QVU devices are reviewed by the Medical Genetics panel. Browse all Medical Genetics devices →