(25 Tests) CLIAwaived H. pylori Whole Blood Rapid Test. A rapid qualitative immunoassay intended to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human whole blood. FDA-cleared and CLIA-waived. (FDA 510K#: K024360)
- Simple one-step test
- Room temperature storage
- Built-in procedural control
- Fast results in 4 minutes
- Sensitive over 95.1%
- Specific over 92.8%
- FDA-cleared and CLIA-waived