Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® HbA1c Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00850011135327
- Basic UDI-DI Code
- B-00850011135327
- Reference
- 605sa
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE HbA1c Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range on automated instrument systems for the following analyte: % Glycohemoglobin A1c (HbA1c).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010504 | HAEMOGLOBIN CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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