Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® FERTILITY 1 Test Se
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00859110005814
- Basic UDI-DI Code
- B-00859110005814
- Reference
- 502re
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE Fertility 1 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: follicle-stimulating hormone (FSH), human chorionic gonadotropin (hCG), luteinizing hormone (LH), prolactin (PRL) and testosterone (TSTO).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152002 | HORMONE CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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