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Product Development

American Bionostica develops new products using Design Control standards consistent with our Quality Systems.  We will develop your assay for a fee, provide samples for validation and then manufacture it at an agreed price.   Product development timelines depend on the effectiveness of available immunoreagents.

Quality Systems

Operations are conducted in compliance with Quality Systems based upon standards of ISO 2859-1 and FDA 21 CFR Part 820. Raw materials, product performance and physical characteristics are inspected and tested in compliance with sampling standards 

Manufacturing

After development and validation of the new assay are completed we integrate the manufacturing process with our Quality Systems to meet your ongoing forecasts. American Bionostica invests in the finest precision manufacturing equipment and maintains redundant systems to insure consistent, reliable supply.