Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 06952062769293
- Basic UDI-DI Code
- B-06952062769293
- Reference
- SL030101NST-X
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Additional Description
This product is used for in vitro qualitative detection of the SARS-CoV-2 antigen in human nasal swab specimen. It is intended for personal use by untrained layman as a rapid test method for novel coronavirus infection. However, please do not make a medical decision without consulting with the doctor.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | No. 1434-IVDD-055/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇧🇪 Belgium
🇵🇱 Poland
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