We are dedicated to our customer`s success through a commitment to exceeding expectations and delivering products with industry leading quality standards.

Since conception, Maxim Biomedical has been committed to meeting the highest standards of quality in the IVD industry. We have consistently maintained our quality system to be FDA registered, cGMP compliant, and ISO13485 certified for the last 15 years. Maxim’s dedication to quality is seen with our routine manufacture of CDRH and CBER regulated products. Our group of skilled developers, scientists, and professionals design and manufacture 510(k), PMA, and BLA regulated products each year. By utilizing our robust quality management system, Maxim is able to provide IVD products that are expertly developed, approved, manufactured, and delivered to market. Maxim handles every step of the IVD development process, from conceptualization to large-scale production. With our turnkey solutions and proven development and manufacturing process, our IVD products are made to ensure the highest level of quality.

Our commitment to quality is demonstrated through:

USP Water Purification System
24/7 Temperature & Humidity monitoring system
Controlled Key-Access Security to all labs
Annual audits conducted internally and by outside vendors/regulatory bodies
Systematic lot release and lot traceability of all products and raw materials
Validated manufacturing processes
Manufacture 510(k) (Class I and II), PMA (Class III), and BLA products
Familiarity and adherence with both CDRH and CBER regulation

Certifications

ISO 5, ISO 7, & ISO 8 Cleanrooms
ISO 13485:2016 Certified
FDA cGMP Registered
FDA CFR820 Compliant

Maxim Biomedical Downloads

Maxim - Model 92001 - 192 Tests HIV-1 Limiting Antigen Avidity (LAg-Avidity) EIA Kit - Brochure

Maxim - Model 92003 - 192 Tests HIV-1 Limiting Antigen Avidity (LAg-Avidity) DBS EIA Kit- Brochure

Maxim Swift - Model 92002 - HIV Recent Infection Assay (RIA) Kit - Brochure

Maxim - Model 700000 - 480 Tests HIV-1 Urine Enzyme Immunoassay (EIA) Kit - Brochure