Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
ONE STEP hCG PREGNANCY TEST
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06970871280068
- Basic UDI-DI Code
- B-06970871280068
- Reference
- midstream 12test
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Qingdao AIBO Diagnostic Co., LTD
Additional Description
One Step hCG Pregnancy Test is a rapid chromatrographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine at a concentration level from 20mIU/ml or greater to aid in the early detection of pregnancy. The test is designed for over-the–counter use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050206 | B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V10972460002 | TÜV SÜD Product Service GmbH | Expired |
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