Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06438115001478
- Basic UDI-DI Code
- B-06438115001478
- Reference
- 67404
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Aidian Oy
Additional Description
The product is a manual, semi-quantitative test for the detection of viable microbes in urine samples. Urinary tract infection (UTI) is one of the most common infections caused by bacteria. Bacterial culture of an appropriately collected and handled urine sample aids in the accurate diagnosis of UTI. The test is intended to be used by healthcare professionals in the clinical laboratory and near-patient testing (NPT) setting (also known as point-of-care setting). For in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0104010703 | URINE SCREENING MANUAL (DIPSLIDES ETC.) |
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