(25 Tests) INSTANT VIEW H. PYLORI WHOLE BLOOD RAPID TEST. This FDA 510K cleared, CLIA Waived, and CE marked test is 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) For professional use only.
- Simple, one-step procedure
- Built-in Control
- Small sample volume required
- 12-18-month shelf life at room temp. (from date of manufacture)
- Speedy results; minimizes user error
- Indicates the test has been performed correctly
- Sample can be run reliably with minimal amount of specimen
- No special storage requirements to maintain stability
- Consistent, on-time supply & ready technical support
