QXS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chromogranin A
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| 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 (K222251) | B.R.A.H.M.S GmbH, Part of Thermo Fisher | 2023-09-18 | + Add |
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Every clearance here is in the API, with alerts when new ones post.