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-C123
- Basic UDI-DI Code
- B-ABT-FT-C123
- Reference
- ABT-FT-C1
- 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 qualititative determination of human chorionic gonadotropin (HCG) in urine to aid the early detection of pregnancy
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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