Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974849366259
- Basic UDI-DI Code
- B-06974849366259
- Reference
- HWTS-RT091A
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
This kit is applicable to in vitro qualitative detection of SARS-CoV-2 variant B.1.617.2 and subsequent rapid differential diagnosis of its main mutation sites L452R, T478K and P681R in suspected COVID-19 cases, suspected COVID-19 cluster cases, and other cases that need diagnostic tests for SARS-CoV-2 infection after testing positive for SARS-CoV-2 in their sputum samples and Pharyngeal swabs.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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