Eu Ivdd
Eu Ivd Self Testing
On The Market
๐จ๐ณ China
HAEMOGLOBIN (HB)
Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1
Basic Information
- Primary DI
- 06941571840302
- Basic UDI-DI Code
- B-06941571840302
- Reference
- R40-112
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Additional Description
The Fecal Occult Blood (FOB) Rapid Test is an colloidal gold method for qualitative detection of human hemoglobin (bleeding) in feces. It is useful in determining gastrointestinal (GI) bleeding in a number of GI disorders. It is used for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010601 | HAEMOGLOBIN (HB) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 107987 0002 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
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