Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-SC20204W-1T2N
- Basic UDI-DI Code
- B-SC20204W-1T2N
- Reference
- SC20204W-1T
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
Additional Description
For the rapid qualitative detection of histidine-rich protein 2 (HRP2) and plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum in human whole blood from individuals who have signs and symptoms consistent with malaria infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090401 | PLASMODIUM (MALARIA) - RT & POC |
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