Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974849366419
- Basic UDI-DI Code
- B-06974849366419
- Reference
- HWTS-RT057F
- 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 intended to in vitro qualitatively detect the ORF1ab and N genes of novel coronavirus (SARS-CoV-2) in the nasopharyngeal swab and oropharyngeal swab samples collected from cases and clustered cases suspected with novel coronavirus-infected pneumonia and others required for the diagnosis or differential diagnosis of novel coronavirus infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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