Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Digital 1 Step Pregnancy Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06934142930014
- Basic UDI-DI Code
- B-06934142930014
- Reference
- 10170
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Tianjin New Bay Bioresearch Co., Ltd.
Additional Description
It iis a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. It is intended for lay user and over the counter use. The test device detects the presence of hCG in the urine of pregnant woman by way of hCG test strip within a plastic cassette, which is integral with the digital component that reads and displays the result of immunochemical reactions on the Display Screen of the test reader in a manner similar to Mistream hCG test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160302 | HCG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2012972-1 | TÜV Rheinland LGA Products GmbH | Expired |
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