Affinity Biologicals, Inc. is a primary manufacturer of products used worldwide in thrombosis and hemostasis research and medical diagnostics.

Our products include an extensive line of antibodies to coagulation and hemostasis related proteins, conjugates, antibody pairs for immunoassay of human and animal analytes, the VisuLize line of complete ELISA kits, and a full line of human plasma products including immune-depleted plasmas, calibrators and controls. Custom Services include protein purification, antibody production, assay development, custom manufacturing and lyophilization.

Affinity has an ISO 13485 registered Quality System and manufactures in vitro diagnostic medical devices licensed by the US Food and Drug Administration, Health Canada and European regulatory authorities (CE Mark).

Please read on to find out more about Affinity Biologicals, Inc. and the products and services we have to offer your organization.

Quality Policy

The management and employees of Affinity Biologicals Inc. endeavour to design, produce and distribute quality products.

Affinity Biologicals Inc. will maintain a documented quality system in accordance with ISO13485 and 21 CFR820 (Quality System Regulations). This system will identify and comply with the regulatory requirements for in vitro diagnostic medical devices as appropriate to meet our customer’s needs.

The regulatory requirements of Canada (CMDR, Canadian Medical Device Regulations), the United States (21 CFR part 800-861 and 864) and Europe (in vitro Diagnostic Directive 98/79/EEC) will apply to in vitro diagnostic products only.

The following commitments support achievement of our quality policies:

  • Management is visibly committed to this quality policy.
  • Empower, educate and train employees to accomplish quality goals.
  • Identification, resolution, correction and prevention of quality problems.
  • Proactively establish and nurture customer relationships to stay abreast of market needs and opportunities.
  • Continuous effort to improve methods and processes.
  • Establish, communicate and monitor quality objectives.
  • Recognize quality achievements throughout the organization.
  • Form cooperative relationships with our suppliers to ensure quality products.
  • Comply with requirements and maintain the effectiveness of the quality management system.
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The values that drive the activities of Affinity Biologicals are:

  • A commitment at all levels to the continuous improvement of our quality system, our manufacturing processes and our business practices. We will always endeavor to provide world-class products and enhance customer satisfaction.
  • Teamwork. We will benefit from the increased potential of individuals working together to solve problems and generate new ideas.
  • A commitment to creating a positive work environment, where individuals are encouraged to develop professionally and personally through continuous learning, and where performance is recognized and rewarded.
  • Integrity. We will always conduct our business and manufacturing practices in an open and ethical manner. We treat our customers, our coworkers and our suppliers with respect.