Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06935091671812
- Basic UDI-DI Code
- B-06935091671812
- 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 to detect the Chlamydia trachomatis antigen in female cervical swab and male urethral swab qualitatively. For professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090101 | CHLAMYDIA AG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | W0105099001 | TÜV SÜD Product Service GmbH | Expired |
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