510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QXSClass II

Chromogranin A

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

QXS is the FDA product code for Chromogranin A, a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXS
Device name
Chromogranin A
FDA 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.
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QXS

By decision year
1 clearance under product code QXS with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXS by decision year
YearClearances
20231

Applicants with the most clearances

Product code QXS
Applicants holding the most 510(k) clearances under product code QXS
ApplicantClearances
B.R.A.H.M.S GmbH, Part of Thermo Fisher1

Companies listing this code with FDA

Companies whose registered establishments list this code