Rapid Thyroid Diagnostic Test Kit Suppliers & Bulk Manufacturers
Available Forms: Lateral flow immunoassay; Point-of-care test strips
Available Strengths: Detects thyroid-stimulating hormone (TSH) rapidly
Reference Brands: BioSign, Chembio, AccuBioTech, OraSure,Rapidfor thyroid test kit
Category:
Rapid Test Kits
This kit is intended for in vitro quantitative determination of the concentration of Thyroid Stimulating Hormone (TSH) in human serum, plasma, and whole blood samples. Automated and objective results in 15 minutes by immunofluorescent assay.
Rapid Thyroid Diagnostic Test kit is available in Lateral flow immunoassay; Point-of-care test strips
and strengths such as Detects thyroid-stimulating hormone (TSH) rapidly.
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, Rapid Thyroid Diagnostic 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) |
Rapid Thyroid Diagnostic 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:
-Rapid thyroid diagnostic test kits are regulated in the EU and US, with dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves validation, safety testing, and clinical evaluation, while in the EU, CE marking certifies conformity with MDR regulations. These kits undergo validation, stability testing, and audits, supported by comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, high-quality thyroid testing solutions supporting early diagnosis and management of thyroid disorders worldwide.
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