Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Ovulation (LH) Enhanced Sensitivity Rapid Test Dipstick
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06970277513579
- Basic UDI-DI Code
- B-06970277513579
- Reference
- FLH-U101H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The LH Ovulation Rapid Test Dipstick (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (hLH) in urine to aid in the detection of ovulation. The result can be read visually in minutes to indicate a positive or negative result for ovulation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160304 | LH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1095123 0008 | TÜV SÜD Product Service GmbH | Expired |
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