Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® VITAMIN D Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00859110005845
- Basic UDI-DI Code
- B-00859110005845
- Reference
- 506ab
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE VIT D Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: total 25(OH) Vitamin D (VIT D).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152006 | ANAEMIA RELATED/VITAMIN CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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