Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT BP Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240176
- Basic UDI-DI Code
- 697349224U2020092C000GU
- Reference
- U20209
- 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 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 |
|---|---|
| W0105011607 | BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS |
Available In Countries
π«π· France
π³π± Netherlands
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