Kit Design and Commercialization:
Through our Custom Diagnostics division, we offer flexible manufacturing to meet your business need. Services include:
- Reagents: We can manufacture reagents under GMP conditions, and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical and clinical diagnostic studies, although our customers have found many other unique and interesting uses.
- Sample Collection Kits: We can provide a CLIA-approved GMP/GLP environment for the manufacture and distribution of your specialized sample collection kit needs. Great for clinical trials where critical reagents need to be formulated, assembled and shipped to clinical sites.
- Custom Diagnostic Kits:We can provide a GMP/GLP environment for the manufacture and distribution of your specialized diagnostic assays. Great for 510(k)/PMA studies where diagnostics needs to be assembled and shipped to multiple external sites.
- Product Manufacturing: Custom Diagnostics can OEM manufacture reagents, kit components, or entire diagnostic assays.