Eu Ivdr
Eu Ivd Class A
On The Market
🇺🇸 United States
NOVEOS flex Immunoassay System
Devices (same UDI-DI)
2
Certificates
0
Countries
8
Notified Bodies
0
Basic Information
- Primary DI
- 00816879028768
- Basic UDI-DI Code
- 081687902NOVINST37
- Reference
- FX64000
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Hycor Biomedical LLC
Additional Description
The NOVEOS® flex Immunoassay System is an in vitro diagnostic medical device used, in combination with NOVEOS® flex Software and accessories, for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. It is an automated device to be used by professional users in a clinical laboratory setting.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020101 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) |
Available In Countries
🇧🇪 Belgium
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇫🇷 France
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇹🇷 Türkiye
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