Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One-step Immunological Hemoglobin and Transferrin Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-6909620WHSFOBTFLHR2
- Basic UDI-DI Code
- B-6909620WHSFOBTFLHR2
- Reference
- WH-FOB-S0x0401; WH-FOB-S0x0402
- 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
One-step Immunological Hemoglobin and Transferrin Test is an immunoassay designed for the qualitative determination of both hemoglobin and transferrin in feces for early detection of fecal occult blood. And the device is intended for self-testing. Currently our products are in the format of strip and Cassette
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160203 | FECAL OCCULT BLOOD - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2101523-1 | TÃœV Rheinland LGA Products GmbH | Expired |
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