Eu Ivdr
Eu Ivd Class A
On The Market
๐ฎ๐ช Ireland
KC 4 Delta
Devices (same UDI-DI)
1
Certificates
0
Countries
8
Notified Bodies
0
Basic Information
- Primary DI
- 05391521421012
- Basic UDI-DI Code
- 53915214KC4UJ
- Reference
- N04000
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Tcoag ireland ltd
Additional Description
The KC 4 Delta is a semi-automated analyser, dedicated to performing coagulation assays, such as PT aPTT and Fibrinogen on human plasma. It is intended to be used by professionals in clinical laboratories. It is used for testing on the general human population of all ages, in diseased and non-diseased states. When either an accelerated or a prolonged clot time is identified by the KC 4 Delta and its associated reagents during testing, this can be used as a screening tool for, or an aid to diagnosis of, coagulation disorders in the patient.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0299 | IVD INSTRUMENTS - OTHER |
Available In Countries
๐ฆ๐น Austria
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ณ๐ฑ Netherlands
๐ต๐น Portugal
๐น๐ท Tรผrkiye
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