Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
INFECTIOUS IMMUNOLOGY - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-697419997WR
- Basic UDI-DI Code
- B-697419997WR
- Reference
- joysbio 01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- JOYSBIO(Tianjin) Biotechnology Co., Ltd.
Additional Description
The antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with exposures history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900299 | INFECTIOUS IMMUNOLOGY - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-218/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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