Audited Supplier
INTENDED USE
The H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgM and IgG antibodies to Helicobacter pylori in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.
INTRODUCTION
The H. pylori Antibody Rapid Test detects IgM and IgG antibodies specific to Helicobacter pylori through visual interpretation of color development on the internal strip.
| Manufacturer | Dewei Medical Equipment Co., Ltd |
| Product Categories | IVD Test |
| Principle | Rapid Colloidal Gold Immunochromatography |
| Detection | Qualitative |
| Storage | 2~30 º C |
| Component | Rapid Test |
| Package | 25T/box, 50T/Box, 100T/Box |
| Trademark | Dewei |
| Origin | China |
MAIN CONTENTS
Test Cassette
Disposable Pipettes
Buffer
Instructions for use
STORAGE AND STABILITY
Store at 2 ~ 30 º C in the sealed pouch for 24 months.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
INTERPRETATION
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research centers, and college laboratories. Quality is the primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA, and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in the IVD field, DEWEI will go on to provide the best service to you with outstanding R&D and cost-effective products.
Certificate
Production Workshop
Transportation
