H. Pylori Antibody Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Cassette-based immunoassay (lateral flow)/Dipstick or strip formats
Available Strengths: high sensitivity (>90%),
Reference Brands: SD Bioline H. pylori, Premier™ H. pylori, CareStart H. pylori Premier™ H. pylori, CareStart H. pylori(US)
Category: Rapid Test Kits
H. pylori Antibody Rapid Test Kits is available in Cassette-based immunoassay (lateral flow)/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 Antibody Rapid Test Kits 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 Antibody Rapid Test Kits 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: H. pylori antibody rapid test kits are approved in the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality. In the US, FDA clearance is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, performance testing, stability assessments, and quality audits. Proper documentation includes safety profiles, clinical efficacy data, and certification details. For comprehensive licensing guidance, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Staying informed ensures reliable, efficient H. pylori screening solutions for clinical use and public health management worldwide.
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