Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
LH One Step Ovulation Test
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 06939663984065
- Basic UDI-DI Code
- B-06939663984065
- Reference
- LH-101/LH-102/LH-103
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The LH One Step Ovulation Test Strip is a rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict time of ovulation. For self-testing and in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160304 | LH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1 095295 0002 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇩🇪 Germany
🇷🇴 Romania
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