Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Malaria P.f/P.v Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260206339
- Basic UDI-DI Code
- B-06933260206339
- Reference
- BT0102101
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The Malaria P.f/P.v Antigen Rapid Test is a lateral flow immunoassay for the qualitative detection of Histidine-Rich Protein II (HRP-II) specific to Plasmodium falciparum (P.f) and Plasmodium lactate dehydrogenase (pLDH) specific to Plasmodium vivax (P.v) in human whole blood specimen. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with Malaria.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105050209 | PLASMODIUM (MALARIA) |
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