Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Leptospira IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06976753475874
- Basic UDI-DI Code
- B-06976753475874
- Reference
- A490501D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
Additional Description
Leptospira IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibody to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with L. interrogans. Any reactive specimen with the Leptospira IgG/IgM Rapid Test Device must be confirmed with alternative testing method(s).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011704 | LEPTOSPIRA |
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