Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT MP Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240169
- Basic UDI-DI Code
- 697349224U2020012C000DL
- Reference
- U20201
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This kit is an automated, in vitro nucleic acid amplification test used for the qualitative detection of the Mycoplasma pneumoniae (MP) in Oropharyngeal swabs samples collected from individuals with suspected signs and/or symptoms of MP infection. This kit can be used for auxiliary diagnosis of Mycoplasma pneumoniae infection, and provides molecular diagnostic basis for MP infection. This kit is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010803 | MYCOPLASMA DETECTION BY NA REAGENTS |
Available In Countries
π«π· France
π³π± Netherlands
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