
Ck-Mb Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Lateral flow immunoassay/Dipstick or strip formats
Available Strengths: Detects CK-MB isoenzyme levels, typically >3-5 ng/mL
Reference Brands: NovaTec CK-MB, Aurora Biomed, Abaxis(US)
Category: Rapid Test Kits
CK-MB Rapid Test Kits is available in Lateral flow immunoassay/Dipstick or strip formats and strengths such as Detects CK-MB isoenzyme levels, typically >3-5 ng/mL. 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, CK-MB 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) |
CK-MB 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: CK-MB 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 clearance is required, while in the EU, CE marking ensures conformity with in vitro diagnostic regulations. These kits undergo rigorous validation, clinical performance testing, stability assessments, and quality audits. Proper documentation includes safety data, performance metrics, and certification details. For detailed licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid cardiac diagnostics to support early myocardial infarction detection worldwide.
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