Regulatory support services for IVD compliance including FDA registration, ISO 13485 quality systems, and global regulatory documentation. Supports LDT, RUO, and IVD approval pathways.
Manufactured by
Calbiotech, Inc
El Cajon, CA, United States
Calbiotech specializes in immunoassay development and manufacturing, with a comprehensive range of ELISA and CLIA assays for human and animal research, including specific assays for hormone, autoimmune disorders, cancer, infectious diseases and much more. The company has over 200 products which are distributed to over 80 countries globally. Calbiotech is a key partner for biotech, pharma and CROs, providing contract manufacturing and assay development services, including custom coated microplates, reagents, buffers and other assay components.
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