BOIRON TEST & CARE
Basic Information
- Primary DI
- 06973861680404
- Basic UDI-DI Code
- B-06973861680404
- Reference
- F6061701
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Suny (Xiamen) Biotechnology Co., Ltd.
Additional Description
This kit is a colloidal gold immunochromatography intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, Influenza A and Influenza B viral in human direct Nasal Swab specimens. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and Influenza can be similar. This kit is suitable for detection symptomatic or asymptomatic SARS-CoV-2, Influenza A and Influenza B suspected cases, patients with suspected clusters or other individuals who need to be diagnostic with SARS-CoV-2, Influenza A and Influenza B infection. Children and adolescents under the age of 18 or people who cannot understand the instructions correctly should take the test under the supervision of an adult or someone who can understand the instructions correctly.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070503 | RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CECERT/073/W/E.2 | CeCert Sp. z o.o. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).