H. pylori Antibody Rapid Test
- UID
- MFG/MD/2018/000041_7caa6965d917ec52151d2f8b3d9ad5d5_336d68d9b4ff8e932d0f103b45ccee56
- Device class
- Class B
- Brand name
- Feces
- License holder
- NULIFE
- Approving authority
- Uttar Pradesh
- Product information
- H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (Feces), culture, and/or histologic staining.3 Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods.4,5 Individuals infected with H.pylori develop antibodies which correlate strongly with histological confirmed H.pylori infection.6,7,8 The H.pylori Antibody Rapid Test Cassette (Feces) is a simple test that utilizes a combination of H.pylori antigen coated particles and anti-human IgG to qualitatively and selectively detect H.pylori antibodies in serum or plasma.
H. pylori Antibody Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000041_7caa6965d917ec52151d2f8b3d9ad5d5_336d68d9b4ff8e932d0f103b45ccee56. This device is marketed under the brand name Feces. The license holder is NULIFE, and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.