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
- D-ABT-FT-A1ZS
- Basic UDI-DI Code
- B-ABT-FT-A1ZS
- Reference
- ABT-FT-A1
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- AccuBioTech Co., Ltd.
Additional Description
One Step HCG Pregnancy Test is a rapid , One--step lateral flow immunoassay for the qualitative determination of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy. It's intended for both prescription use and over-the-counter use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160302 | HCG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2187098-1 | TÜV Rheinland LGA Products GmbH | Expired |
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