SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)
Basic Information
- Primary DI
- 06971348761042
- Basic UDI-DI Code
- B-06971348761042
- Reference
- MF-68-1
- 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 Antigen Test Kit is applicable to the qualitative detection novel Coronavirus (SARS-CoV-2) Nucleocapsid protein in population Nasal swabs samples in vitro. It is intended as an aid in the diagnosis of coronavirus infection disease (COVID-19) for symptomatic patients within 7 days after onset of symptoms, which is caused by SARS-CoV-2. For in vitro diagnostic use only. For self-testing use. The application of this test kit has been tested in a study consisting of people between 18 and 75 years of age. For persons under 18 of age, use only under adult or family supervision. For persons above the age of 75, provide assistance as appropriate. it is for presumptive screening only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-081/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
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