BOIRON
Basic Information
- Primary DI
- 06973861680466
- Basic UDI-DI Code
- B-06973861680466
- Reference
- B606102
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Anbio (Xiamen) Biotechnology Co.,Ltd.
Additional Description
The COVID-19 antigen rapid test is a colloidal gold immunochromatography test for the qualitative detection of nucleocapsid antigens from SARS-Cov-2 in human nasal swabs. It is suitable for use by people who are suspected of having a COVlD-19 disease-symptomatic individuals and asymptomatic individuals who have been in contact with infected people. Suitable for 3 years old and above, children and adolescents under the age of 18 or people who cannot understand the instructions of use correctly should only take the test under the supervision of an adult or someone who can fully understands the instructions of use correctly.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-068/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
Similar Devices
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