Eu Ivdr
Eu Ivd Class A
On The Market
🇨🇳 China
MEASUREMENT DEVICES - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 06975318150133
- Basic UDI-DI Code
- 697531815anitoa0013B
- Reference
- pixl Real-Time PCR Platform
- Device Types
-
New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Anitoa Biotechnology （Hangzhou）Co.,Ltd.
Additional Description
This device is suitable for in vitro qualitative detection of Coronavirus (2019-nCoV) ORF1ab and N gene of the new coronavirus infection in suspected pneumonia cases,suspected clustered patients,and other patients who need to diagnose or differentially diagnose new coronavirus infections in throat swabs, nasal swabs, plasma and serum samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V0399 | MEASUREMENT DEVICES - OTHER |
Available In Countries
🇪🇸 Spain
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