Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One-Step FSH Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- D-6909620WHSFSH9MLB
- Basic UDI-DI Code
- B-6909620WHSFSH9MLB
- Reference
- WH-FT-S0x0301; WH-FT-S0x0302; WH-FT-S0x0303; WH-FT-S0x0307
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- W.H.P.M. Bioresearch & Technology Co., Ltd.
Additional Description
The WH Accu TestTM FSH Test is an self-testing immunochromatographic one step assay designed for in vitro qualitative determination of FSH in human urine to evaluate the onset of menopause in women at concentration of 25 mIU/mL or higher.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160301 | FSH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2101523-1 | TÜV Rheinland LGA Products GmbH | Expired |
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