Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One Step LH Ovulation Rapid Test Kit(Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06935091671997
- Basic UDI-DI Code
- B-06935091671997
- Reference
- /
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
Additional Description
The reagent is used to detect the LH in human urine qualitatively according to the principle of double antibody sandwich method.For self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160304 | LH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 093780 0004 Rev. 01 | TÜV SÜD Product Service GmbH | Expired |
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