DeviceClearance

Product code QXS— Immunology

B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

Classification name
Chromogranin A
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QXS under 21 CFR 866.6010, via openFDA

Market context for product code QXS

FDA has cleared 1 device under product code QXS, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXS

Recent clearances under product code QXS

Data sourced from openFDA. This site is unofficial and independent of the FDA.