Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT MG Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240145
- Basic UDI-DI Code
- 697349224U2030022C000EQ
- Reference
- U20302
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This assay is an automated, in vitro nucleic acid amplification test used for the qualitative detection of Mycoplasma genitalium (MG) deoxyribonucleic acid (DNA) in urine samples from asymptomatic and symptomatic individuals, and is used as an aid in clinical diagnosis of MG infection. This assay 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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