Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One-Step Immunological Fecal Occult Blood Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-6909620WHSFOB8VJY
- Basic UDI-DI Code
- B-6909620WHSFOB8VJY
- Reference
- WH-FOB-S0x0101; WH-FOB-S0x0102
- 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
Hemosure® One-step Immunological Fecal Occult Blood Testis a rapid, convenient and odorless qualitative, sandwich dye conjugate immunoassay for the determination of human occult blood in feces, and is a useful aid in the diagnosis of gastrointestinal disorders. Currently our products are in the format of cassette and strip. All products are packed and sealed in aluminum foil bags to ensure its validity before its expiration and equipped the buffer tube with them.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010601 | HAEMOGLOBIN (HB) |
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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