Viralab is currently preparing documents and data for 510(k) submission for Helicobacter pylori IgG ViraStripe and Helicobacter pylori IgA ViraStripe. Both of these products have CE marks and are being used for clinical applications in Europe. Our progress with these two products is progressing smoothly. Viralab is seeking Clinical Laboratories in the United States to participate in the "Prospective Studies" required for comparisons between the IgG and IgA H. pylori ViraStripe assays and the predicate EIA methodologies. The new Helicobacter assays from Viramed Biotech are being submitted as equivalent to the EIA test method but offer additional testing information by the use of purified H. pylori antigens including VacA, CagA, and Urease. Final release of these products are expected in the spring of 2015. Kits are available for Investigational Use Only at this time.
V-HPSGOK H. pylori IgG Test Kit
V-HPSAOK H. pylori IgA Test Kit