Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-SC30107W-1T3V
- Basic UDI-DI Code
- B-SC30107W-1T3V
- Reference
- SC30107W-1T
- Device Types
-
Single use
- 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 is a rapid chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens, nasopharyngeal swab specimens or oropharyngeal swab specimens from symptomatic individuals who are suspected of COVID-19 or asymptomatic individuals who have had contact with confirmed COVID-19 patients but didn't show any symptoms.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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