Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240176
- Basic UDI-DI Code
- B-06973492240176
- Reference
- U20209
- 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 deoxyribonucleic acid (DNA) of bordetella pertussis (BP) in samples from nasopharyngeal swabs from suspected case with signs and/or symptoms of respiratory infection.. It is used in the auxiliary diagnosis of pertussis infection. This kit is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries