QXS
- Product code
- QXS
- Device name
- Chromogranin A
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K222251 | 2023-09-18 | B.R.A.H.M.S GmbH, Part of Thermo Fishe… | B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPT… |
Official FDA classification page: QXS
Classification and pathway per current FDA publications. Data from openFDA (CC0).