Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 07090028595100
- Basic UDI-DI Code
- 709002859510BG
- Reference
- CAL0510, CAL0510L
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Calpro AS
Additional Description
The device is intended for sampling and extraction of human stool samples for fecal calprotectin analysis. The sampling can be performed by patient, but the extraction and analysis only by labortatory staff. The device is prefilled with extraction buffer. The extract can be analyzed with Calporlab Calprotectin ELISA or CalproGold Turbidimetric assay.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W05019001 | FAECES COLLECTION DEVICES |
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