Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-test
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- D-SC30107SW-5T7M
- Basic UDI-DI Code
- B-SC30107SW-5T7M
- Reference
- SC30107SW-5T
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
Additional Description
The Bioperfectus Technologies Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-test) is a lateral flow test intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in human nasal swab samples. It is used to detect symptomatic individuals who are suspected of COVID- 19 or asymptomatic individuals who have had contacted with confirmed COVID-19 patients but do not show any symptoms. This test is authorized for non-prescription home use with self-collected nasal swab specimens directly fiom individuals aged 18 years and older.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).