ONE STEP H. pylori Ag Test

Trade name

ONE STEP H. pylori Ag Test

06936155807130

B-06936155807130

Reference / catalog number

ITP10003-DS50

GS1

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

ONE STEP H. PYLORI Ag Test is a rapid, serological, immunochromatographic assay for the detection of Helicobacter pylori antigen (Hp) in human feces sample. The test is used to obtain a visual, qualitative result. This test is a rapid test as an aid in the diagnosis of relative infection and relative symptom; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate test to make final decision. The test is intended for healthcare professional use. Helicobacter pylori is a spiral-shaped bacterium associated with gastric and duodenal diseases, including gastritis, gastric ulcer and duodenal ulcer, and H. pylori antigen in feces can be detected using immunochromatographic techniques. The assay is based on a one-step chromatographic immunoassay principle. When the feces sample is applied to the sample pad, H. pylori antigen in the sample reacts with anti-HP conjugates and migrates along the membrane by capillary action. If H. pylori antigen is present, it is captured in the test region to form a colored test band. The control band indicates that the test is working properly and the result is valid.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105010401H. PYLORI ANTIGEN DETECTION

5 warnings recorded — scroll inside the panel to see all entries.

• CW011

  For professional in vitro diagnostic use only. Follow the instructions for use carefully.
• CW009

  The test is for single-use. Do not resue
• CW010

  Package insert instructions should be carefully read before testing. Avoid cross-contamination of feces samples by changing to a new specimen pipette for each sample.All positive or questionable results should be evaluated together with clinical diagnosis and laboratory findings.
• CW008

  All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.; Biological risks: The test device should be discarded in a proper biohazard container after testing.
• CW032