Eu Ivdd
Eu Ivd General
On The Market
🇮🇪 Ireland
Multichem A1c
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- 05391523440844
- Basic UDI-DI Code
- B-05391523440844
- Reference
- HB002A
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Techno-path Manufacturing Ltd.
Additional Description
Multichem A1c control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte, HbA1c as listed in the package insert.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050205 | DIABETES CONTROLS |
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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