Can you manufacture ASR- and/or IVD-labelled products for us?
No. The FDA does not currently permit distribution of antibody cocktails, which identify multiple analytes, under the ASR designation. We will take your proprietary cocktail and manufacture it to your specifications in an ISO 9001-compliant facility following good manufacturing practices. As part of this strictly confidential process, you’ll receive your products labelled only with:
- A brief description
- Unique part and lot numbers
- Any applicable warnings