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Description

  • Qualitatively detects anti-Helicobacter pylori antibody in whole blood (from anticoagulated or fingerstick), serum, or plasma specimens
  • Used as an aid in the diagnosis of H. pylori infection in adult patients with symptoms of gastrointestinal disorders
  • Delivers rapid results in ten minutes
  • Simple to use - add sample and buffer
  • Individually packaged test cassettes help maintain the quality
  • Each test device contains a membrane strip coated with H. pylori antigen and a pad with indicator conjugates in a protein matrix
  • Includes 10 capillary tubes to contain each specimen separately and avoid cross-contamination
  • Includes one dropper bottle of developer solution containing sodium azide (0.1%) as a preservative
  • For in vitro diagnostic use only
  • For prescription use only
  • 15-month shelf life
  • Store in a cool, dry, well-ventilated area between 35°F (2°C) and 85°F (30°C)
  • Not Made with Natural Rubber Latex
  • Packaged: 10 Per Box, 150 Boxes Per Case

Product Specs

Item Number 1195812
Catalog Number 181-37010
UOM KT
Level 1 Family Description Lab-Waived Lab
Level 2 Category Description Lab-Rapids
Level 3 Group Description H Pylori - Visually Read Reage
Level 4 Sub-Category Description H.Pylori - Visually Read Reagents
Application H. Pylori Test Kit
Brand McKesson Consult
Buy American Act (BAA) Compliant Yes
CLIA Classification CLIA Waived for Whole Blood / CLIA Moderate Complexity for Serum, Plasma
CLIA Classified CLIA Waived Sample Dependent
Contents 1 (10) Test Cassettes, (10) Capillary Tubes, Dropper Bottle of Developer Solution, Instructions for Use, Procedure Card
Country of Origin United States
Manufacturer McKesson Brand
Manufacturer # 181-37010
McKesson # 1195812
Number of Tests 10 Tests
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Whole Blood / Serum / Plasma Sample
Specialty Immunoassay
Test Format Cassette Format
Test Kit Type Rapid
Test Name H. Pylori
Test Type Infectious Disease Immunoassay
Time to Results 10 Minute Results
Trade Agreement Act (TAA) Compliant Yes
UNSPSC Code 41116129

Frequently asked questions

How quickly can I get diagnostic results?

The McKesson Consult H. Pylori Test Kit is designed for efficiency, providing reliable qualitative results in just 10 minutes.

Does this kit support various sample types?

Yes, the kit is highly versatile and compatible with the following sample types:

  • Whole Blood (fingerstick or anticoagulated)
  • Serum
  • Plasma
Is this kit CLIA-waived for clinical use?

The classification depends on the sample type used:

  • CLIA Waived: When using whole blood samples.
  • CLIA Moderate Complexity: When using serum or plasma.
Are all necessary components included in the package?

Yes, this is a complete diagnostic package. Each kit contains:

  • 10 individually packaged Test Cassettes
  • 10 Capillary Tubes for precise specimen handling
  • 1 Dropper bottle of Developer Solution
  • A comprehensive Procedure Card and Instructions for Use
How does the kit prevent cross-contamination?

The kit prioritizes clinical safety by providing 10 individual capillary tubes, ensuring each specimen is handled separately and securely during the testing sequence.

Is the material safe for patients with latex allergies?

Yes, the McKesson Consult H. Pylori Test Kit is proudly not made with natural rubber latex, making it a safer option for patients with latex sensitivities.

What are the proper storage requirements?

To maintain the integrity of the test components, please store the kit in a cool, dry, and well-ventilated area with a temperature range between 35°F (2°C) and 85°F (30°C).

How long is the shelf life for these tests?

The test kits have a shelf life of 15 months, allowing for reliable stock management in clinical or office settings.

Is this product manufactured in the United States?

Yes, this product is manufactured in the United States and is fully compliant with both the Buy American Act (BAA) and the Trade Agreement Act (TAA).

Is this test suitable for professional clinical settings?

Absolutely. This is a professional-grade, prescription-only immunoassay kit designed specifically for primary care offices, gastroenterology clinics, and urgent care facilities requiring rapid, point-of-care diagnostic support.