Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® FIBRINOGEN Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00859110005128
- Basic UDI-DI Code
- B-00859110005128
- Reference
- 904il
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE Fibrinogen Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Fibrinogen activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on IL TOP® analyzers
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103020799 | HAEMOSTASIS CONTROLS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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