An ISO 13485-certified and FDA-registered contract development and manufacturing organization, IVD Research in Carlsbad produces in vitro diagnostic test kits for infectious disease detection from its Sea Lion Place facility. Founded in 1996, the company's Microwell ELISA product line detects Giardia, Cryptosporidium, Entamoeba histolytica, Strongyloides, and Fasciola from stool, urine, and serum samples, supplying clinical sites including Scripps HealthExpress Carlsbad. The Carlsbad operation licensed a novel onchocerciasis biomarker from Scripps Research in La Jolla in 2018, expanding its tropical and neglected-disease diagnostic portfolio. Sister company SafePath Laboratories holds a USDA biologics manufacturing license at the same address, and the combined entity maintains distribution relationships that extend to community clinical settings near Carlsbad Village Pharmacy in the Village district. The CDMO's highest-complexity contracts involve custom lateral flow and rapid-format assay development with validated sensitivity and specificity thresholds for FDA 510(k) and De Novo classification submissions.