Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® TUMOR MARKERS Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00859110005722
- Basic UDI-DI Code
- B-00859110005722
- Reference
- 407re
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE Tumor Markers 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 analytes: cancer antigen 15-3 (CA 15-3), cancer antigen 19-9 (CA 19-9), cancer antigen 125 (CA 125) and carcinoembryonic antigen (CEA).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152005 | TUMOUR MARKER CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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