Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06935091671782
- Basic UDI-DI Code
- B-06935091671782
- Reference
- /
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
Additional Description
The reagent is used for in vitro qualitative detection of TOXO IgM and IgG antibody in human serum/plasma /whole blood, suitable for auxiliary diagnosis of TOXO recent and past infection and the epidemiological investigation of TOXO infection. For professional useonly.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090499 | PARASITES - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 093780 0004 | TÜV SÜD Product Service GmbH | Expired |
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