Eu Ivdr
Eu Ivd Class A
On The Market
🇯🇵 Japan
cobas e 411 analyzer (disk system)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04015630937103
- Basic UDI-DI Code
- 761333601321A3
- Reference
- 04775201001
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Hitachi High-Tech Corporation
Additional Description
The cobas e 411 analyzer hardware is available in two variants, either with a rack sampling unit (cobas e 411 analyzer (rack system)) or a sample disk system (cobas e 411 analyzer (disk system)). The sampling systems are pre-installed as an integral part of the hardware. Apart from the sampling system, there are no differences in these two device variants. The cobas e 411 Analyzer is an automated analyzer including software, intended for running qualitative, semi-quantitative and quantitative immunochemistry assays.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020101 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) |
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