Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT GBS Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240183
- Basic UDI-DI Code
- 697349224U2030112C000EU
- Reference
- U20311
- 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 qualitative diagnosis of Group B Streptococcus (GBS) deoxyribonucleic acid (DNA) in vaginal swab. This kit is indicated as an aid in determining GBS colonization status in antepartum and intrapartum women. This kit is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011102 | STREPTOCOCCAL DETECTION BY NA REAGENTS |
Available In Countries
π«π· France
π³π± Netherlands
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