FDA Product Code QYD: Adalimumab Assay
An In Vitro Diagnostic Device Intended For The Measurement Of Adalimumab, An Anti-tumor Necrosis Factor Alpha Monoclonal Antibody
Leading manufacturers include Procisedx, Inc..
1
Total
0
Cleared
543d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Adalimumab Assay Devices (Product Code QYD)
1 devices
About Product Code QYD - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QYD since 2023, with 0 receiving FDA clearance (average review time: 543 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QYD devices are reviewed by the Toxicology panel. Browse all Toxicology devices →