SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
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Basic Information
- Primary DI
- 06971348761318
- Basic UDI-DI Code
- B-06971348761318
- Reference
- MF-71-2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shenzhen Microprofit Biotech Co., Ltd.
Additional Description
The fluorecare® SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit is applicable to the simultaneous qualitative detection and differentiation in vitro of novel Coronavirus (SARS-CoV-2) antigen, Influenza A virus antigen, Influenza B virus Antigen, and/or RSV antigen in nasal swab samples. It can be used as an aid in the diagnosis of coronavirus infectious disease (COVID-19) caused by SARS-CoV-2 in symptomatic patients within 7 days of onset and in the diagnosis of diseases caused by Influenza A/B or RSV. For in vitro diagnostic use only. For self-testing use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070399 | MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/092/W/E.2 | CeCert Sp. z o.o. | Expired |
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