Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-test)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-SC30107SW-15T82
- Basic UDI-DI Code
- B-SC30107SW-15T82
- Reference
- SC30107SW-15T
- 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 |
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