H. Pylori Antigen Rapid Test Kit Suppliers & Bulk Manufacturers
Available Forms: Cassette-based immunochromatographic test kits/Dipstick or strip formats
Available Strengths: high sensitivity (>90%)
Reference Brands: Premier Platinum H. pylori, Schutz, Nova Test, Abnova H. pylori(US)
Category:
Rapid Test Kits
H. pylori antigen rapid test kits detect active infection by identifying specific H. pylori antigens in stool samples. They work via immunoassay, providing quick and reliable results within 10-15 minutes. Benefits include non-invasive diagnosis, early detection, prompt treatment initiation, and improved patient care in both clinical and point-of-care settings.
H. pylori Antigen Rapid Test Kit is available in Cassette-based immunochromatographic test kits/Dipstick or strip formats
and strengths such as high sensitivity (>90%).
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, H. pylori Antigen Rapid Test Kit is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
H. pylori Antigen Rapid Test Kit can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
H. pylori antigen rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality in compliance with GMP and IVDR standards. In the US, FDA approval is required, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. These kits undergo rigorous validation, clinical performance testing, and stability assessments. Proper documentation includes safety profiles, clinical performance data, and manufacturing details. For detailed licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid detection of active H. pylori infection, supporting effective diagnosis and treatment worldwide.
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