Borrelia B31 ViraStripe IgG


Borrelia B31 ViraStripe IgM


Bordetella pertusis ViraStripe IgG


Bordetella pertussis ViraStripe IgA


Helicobacter pylori ViraStripe IgG


Helicobacter pylori ViraStripe IgA


​Borrelia B31 ViraChip IgG   


Borrelia B31 ViraChip IgM 

Helicobacter pylori

Product Information for Lyme Testing, Bordetella pertussis, & Helicobater pylori

As a Class 1 Device, Viramed Biotech has filed the B. pertussis Immunoblot for Clinical Testing.  This product is intented for InVitro Diagnostic use in the testing of human serum for the presence of human antibodies to B. pertussis PT (pertussis toxin) and FHA (Filamentous Hemagglutinin) antigens. The B. pertussis VIraStripe utilizes Bordetella specific antigens:FHA and PT. Every strip has an integrated control system including serum control, conjugate control, and cut-off control. The PT (28 kD) in charaterized specific for B. pertussis. The antigen FHA (220kD) is characterized specific for Bordetella species. 

Bordetella pertussis ViraStripe:     
B. Pertussis IgG ViraStripe​                                                       
V-BPSGOK  50 Determinations

B. Pertussis IgA ViraStripe
V-BPSAOK   50 Determinations

Controls and Reagents (for ViraStripe Use):
V-BPSGPK     B. pertussis IgG Positive Control
V-BPSAPK     B. pertussis IgA Positive Control
V-BPSPNK     B. pertussis Negative Control

List of Products

Bordetella pertussis

Borrelia B31 ViraStripe:
Borrelia burgdorferi IgG Testing
V-BBSGUS       50 Determinations
V-BBSGDS       500 Determinations


Borrelia burdorferi IgM Testing
V-BBSMUS      50 Determinations
​V-BBSMDS      500 Determinations


Controls and Reagents
(For ViraStripe):
V-BBSGPK Borrelia IgG Positive Control
V-BBSMPK Borrelia IgM Positive Control
V-BSSPNK Borrelia Negative Control
The following products are FDA cleared for In-vitro Diagnostic use in U.S. Laboratories.
The Viramed Borrelia B31 ViraChip and ViraStripe Lyme confirmatory assays conform to criteria as defined by the CDC. These products are a  direct replacement for all Lyme Western blot products.

Lyme Testing

Borrelia B31 ViraChip:
Borrelia burgdorferi IgG Testing
V-BBCGOK       50 Determinations
V-BBCGDK       500 Determinations


Borrelia burdorferi IgM Testing
V-BBSMOK     50 Determinations
​V-BBSMDK     500 Determinations


Controls and Reagents
(For ViraChip):
V-BBCGPK Borrelia IgG Positive Control
V-BBCMPK Borrelia IgM Positive Control
V-BSCPNK Borrelia Negative Control
FDA Clearance in Preparation

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.


Helicobacter pylori ViraStripe:
H. pylori IgG Test Kit 
V-HPSGOK     50 Determinations


H. pylori IgA Test Kit
V-HPSAOK    50 Determinations

Flyers:

Borrelia B31 ViraChip                                    Borrelia B31 IgG and IgM ViraStripe