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In August 2024, Eurofins acquired Orchid Cellmark [36] a UK based DNA and forensic testing company. In September 2024, Eurofins acquired Infinity Laboratories, Inc., based in Castle Rock, Colorado. This increased Eurofins' biopharmaceutical and medical device network in the USA. [37]
In the fourth quarter of 1998, the company acquired GDXI, which undertakes the capture and interpretation of electrocardiograms, and Berkeley Antibody Company, which provides contract services in custom antibody production, applied immunology, and custom animal testing to support the medical device industry and preclinical evaluations, for a ...
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Lancaster Laboratories was founded by Dr. Earl H. Hess in 1961 as a 2,500-square-foot (230 m 2) lab with three employees, including the first lab tech, John Snyder.Earl Hess opened the company intending to provide analytical services to area agribusinesses and industries.
In November 2020, Hologic won a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, Wisconsin, Maine, and California, with the goal to provide 13 million COVID tests per month by January 2022.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
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