Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT CT/NG Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240121
- Basic UDI-DI Code
- 697349224U2030012C000EB
- Reference
- U203001-20
- 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 to qualitatively detect the nucleic acid of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in the secretions of the male urinary tract and female genital tract from symptomatic and asymptomatic people. This kit can be used as an aid in the clinical diagnosis of CT and/or NG infections.This kit is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070501 | STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPPβ¦.) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] |
Available In Countries
π«π· France
π³π± Netherlands
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