Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® Whole Blood Glucose Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00859110005951
- Basic UDI-DI Code
- B-00859110005951
- Reference
- 607ro
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE Whole Blood Glucose 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: glucose.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050202 | LIPID CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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