RapidKey COVID-19 Antigen Self Test (7)
Basic Information
- Primary DI
- 08885013959543
- Basic UDI-DI Code
- B-08885013959543
- Reference
- 301114
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
The RapidKey COVID-19 Antigen Self Test for the novel coronavirus (SARS-CoV2, which causes COVID-19) is a diagnostic test. The test is to be used as an aid in the rapid diagnosis of infection with SARS-CoV-2. The test is used for the direct and qualitative detection of viral protein (the antigen: N protein) of SARS-CoV-2 in nasal mucus. The rapid test uses highly sensitive antibodies to measure the N protein. With this self-testing test, you can find out if you are infected with the virus caused COVID-19. To be used as a self-test from the age of 16. For children under the age of 16, a legal guardian will perform the test or the test will be done under their supervision.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2074998-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).