Basic Information
- Primary DI
- 05060169695771
- Basic UDI-DI Code
- 5060169695771YQ
- Reference
- IS-AI26000
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Immunodiagnostic Systems Limited
Additional Description
The IDS Calprotectin assay is an in vitro diagnostic device intended for the quantitative determination of calprotectin, a neutrophilic protein that is a marker of mucosal inflammation, in human stool on the IDS system. Results are to be used in conjunction with information obtained from the patients’ clinical evaluation and other diagnostic procedures as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome (IBS).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102109099 | AUTO-IMMUNE DISEASE TESTS - OTHER |
Available In Countries
Related Devices
The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.
IDS Calprotectin Extraction Device
DeviceIDS Calprotectin Control Set
DeviceIDS Calprotectin Calibrator Set
DeviceSimilar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).