Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06935091671775
- Basic UDI-DI Code
- B-06935091671775
- 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 antibody in human serum/plasma /whole blood, suitable for auxiliary diagnosis of TOXO recent infection and the epidemiological investigation of TOXO infection. For professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090499 | PARASITES - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1093780 0004 | TÜV SÜD Product Service GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).
master diagnostica
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·VITRO, S.A.·On the market
Vitamin B1 & B6 Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Methylmalonic Acid Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Cortisol & Cortisone Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Vitamin A & E Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Metanephrines Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market