Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)
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Basic Information
- Primary DI
- 06974849366167
- Basic UDI-DI Code
- B-06974849366167
- Reference
- HWTS-RT078A
- 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 conduct, in vitro qualitatively, the rapid differential diagnosis of main mutation sites P681H and HV69-70del of B.1.1.7 mutant strain, main mutation sites E484K and K417N of B.1.351 and P.1 mutant strains, and their common mutation site N501Y for the cases and clustered cases suspected with SARS-CoV-2-infected pneumonia and other cases required for the diagnosis of SARS-CoV-2 infection, positive for SARS-CoV-2 ORF1ab gene in the sputum and throat swab samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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