ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)
Basic Information
- Primary DI
- 06974521001904
- Basic UDI-DI Code
- B-06974521001904
- Reference
- SUPG016025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shenzhen Superbio Technology Co.,Ltd.
Additional Description
The ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold) is a rapid, immunochromatographic assay for the qualitative detection of the specific soluble protein, histidine-rich protein Ⅱ (pf HRP Ⅱ ), which is present in and released from infected red blood cells. The assay does not require additional instruments. This test is a rapid test as an aid in the diagnosis of relative infection and relative symptom; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate test to make final decision.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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