FDA Product Code QXS: Chromogranin A
In Vitro Test To Measure Chromogranin A (cga) As An Aid In Monitoring During The Course Of Disease And Treatment In Patients With Gastroentero-pancreatic Neuroendocrine Tumors.
Leading manufacturers include B.R.A.H.M.S GmbH, Part of Thermo Fisher.
1
Total
1
Cleared
418d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Chromogranin A Devices (Product Code QXS)
1 devices
About Product Code QXS - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QXS since 2023, with 1 receiving FDA clearance (average review time: 418 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QXS devices are reviewed by the Immunology panel. Browse all Immunology devices →