Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 80536089416976
- Basic UDI-DI Code
- 805360894ES000044Z
- Reference
- ES00004-AV6
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Edif Instruments S.r.l.
Additional Description
The ES00004-AV6 analyzer is a configurable device that is used for photometric analysis for qualitative and quantitative in-vitro determinations of human origin specimens.The Kit contains: Core - Automated Immunochemistry Analyser ANL00004-A / Software Hi SFT-HI01-05 / Kit Accessories QCA Bio 100 (669400) ACC07201G-001A.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201010101 | CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) |
| W0201020102 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) |
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