Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974849366150
- Basic UDI-DI Code
- B-06974849366150
- Reference
- HWTS-RT056A
- 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 was intended for In Vitro qualitatively detecting nucleic Acid of SARS-CoV-2 in specimen of throat swabs from suspects of COVID-19, possible clustering cases of COVID-19 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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