Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® BODY FLUIDS 3 Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00850011135389
- Basic UDI-DI Code
- B-00850011135389
- Reference
- 207RO
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE BF3 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 in automated instrument systems for the following analytes: cancer antigen 19-9 (CA 19-9) and carcinoembryonic antigen (CEA).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050102 | UNASSAYED MULTICOMPONENT CONTROLS (CC) |
| W0101050101 | ASSAYED MULTICOMPONENT CONTROLS (CC) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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