Eu Ivdd
Eu Ivd General
On The Market
🇮🇪 Ireland
Multichem hsTn
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 05391523440189
- Basic UDI-DI Code
- B-05391523440189
- Reference
- HS301A
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Techno-path Manufacturing Ltd.
Additional Description
Multichem hsTn is intended for use as a single level quality control material to monitor the precision of highly sensitive Troponin applications on automated analysers for the analytes listed in the package insert.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021306 | TROPONIN I/T |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 103852 0001 | TÜV SÜD Product Service GmbH | Expired |
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