Instant View H. pylori Whole Blood Rapid Test
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)
The Instant-View® H. pylori whole blood test is a lateral flow immunoassay for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum and whole blood. This test is to be used as an aid in the diagnosis of H. pylori infection. Helicobacter pylori is associated with a variety of gastro-intestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal, and gastric adenocarcinoma. Specific antibodies to H. pylori are developed in individuals infected with H. pylori; therefore, the detection of the specific antibodies to H. pylori is used in the diagnosis of H. pylori infection. The test is for healthcare professional use only and is available in cassette format.
H. pylori whole blood cassette test:
Method: Lateral flow test
Sample: Whole Blood
Read Time: 2-3 minutes
Storage: Room temperature
Shelf Life: 12-18 months from date of manufacture
- 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
Made in U.S.A.
Order No. ALF-05-9475
CLIA: Moderately Complex/Non-Waived
FDA Cleared/CLIAwaived (Whole Blood)