Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT UU Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240213
- Basic UDI-DI Code
- 697349224U2030032C000F5
- Reference
- U20303
- 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 is an automated, in vitro nucleic acid amplification test used for the qualitative diagnosis of Ureaplasma Ureaplasma(UU) deoxyribonucleic acid (DNA) in male urinary tract swab and female cervical swab samples from individuals of symptomatic or asymptomatic infection with UU. It is used in the auxiliary diagnosis of Ureaplasma urealyticum (UU) 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
π³π± Netherlands
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