Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
STREPTOCOCCAL DETECTION BY NA REAGENTS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240183
- Basic UDI-DI Code
- B-06973492240183
- Reference
- U20311
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- 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 |
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