Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260206421
- Basic UDI-DI Code
- B-06933260206421
- Reference
- BT0300502
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The kit is used for in vitro qualitative detection of 2019 novel coronavirus (SARS-CoV-2) RNA in upper respiratory tract specimens (nasopharyngeal extracts) in suspected patients with Corona Virus Disease 2019 (COVID-19) . It is considered as an aid in the diagnosis of COVID-19.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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