Helicobacter pylori
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 2021. Kits are available for Investigational Use Only at this time.
Helicobacter pylori ViraStripe:
H. pylori IgG Test Kit
V-HPSGOK 50 Determinations
H. pylori IgA Test Kit
V-HPSAOK 50 Determinations
Controls and Reagents (for ViraStripe Use):
V-HPSGPK H. Pylori IgG Positive Control
V-HPSAPK H. Pylori IgA Positive Control
V-HPSPNK H. Pylori Negative Control
Other Products
Universal Kit Reagents
V-UVNAKI Universal Anti-Hu IgA Conjugate
V-UVNGKI Universal Anti-Hu IgG Conjugate
V-UVNMKI Universal Anti-Hu IgM Conjugate
V-UVNUWP Immunoblot Wash Solution Concentrate
V-UVNUMP Immunoblot Wash Powder V-UVNUCS Immunoblot Substrate Solution
Immunoblot Incubation trays
V-UVNUIG 50 well Black trays (Pack of 10)
Available Equipment
Viramed Biotech:
ViraCam (FDA registered)
ViraChip Reader (FDA registered)
Bee Robotics:
Beeblot 50 Immunoblot Processor (FDA registered)
Stratec:
Gemini Processor (FDA registered)