Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974849366273
- Basic UDI-DI Code
- B-06974849366273
- Reference
- HWTS-RT095A
- 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
The kit is intended for In Vitro qualitatively detecting the ORF1ab gene and N gene of SARS-CoV-2 in specimen of pharyngeal swabs from suspected cases, patients with suspected clusters or other persons under investigation of SARS-CoV-2 infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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