Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06419587022604
- Basic UDI-DI Code
- B-06419587022604
- Reference
- 602260
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
BIOHIT Calprotectin test is a quantitative in vitro enzyme-linked immunosorbent assay (ELISA) aiding in diagnosis of organic disease of the small or large intestine or the stomach such as inflammatory bowel disease, ulcerative colitis or Crohn’s disease by detecting calprotectin in stool samples. In addition, the test is used to monitor the disease activity and the response to treatment in patients with ulcerative colitis or Crohn’s disease. The test can be conducted either manually or automatically and is intended to be used by healthcare professionals only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102019009 | CALPROTECTIN |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).