Company
PROFILE
Alfa Scientific Designs, Inc. is a California-licensed, cGMP compliant, and ISO13485 registered manufacturer of in-vitro diagnostic devices. Founded in 1996, ALFA leads the industry in developing and manufacturing high quality rapid in-vitro diagnostic devices serving the point-of-care medical marketplace. Since 1996, Alfa has developed over fifty products; most of them are FDA cleared and European CE marked. Up to date Alfa has submitted twenty eight patent applications in the USA and Europe; nine of them have been granted and issued.
PRODUCTS
Alfa specializes in rapid immunoassays for the detection of drugs of abuse, fertility hormones, infectious diseases, cardiac and cancer markers, and other diagnostic areas. Alfa has the most comprehensive family of high-quality diagnostic products in cassette and dip strip format to test urine, serum, whole blood and oral fluid specimens.
FACILITIES
Located in Poway, CA, Alfa manufactures its products in a 40,000 square foot state of the art manufacturing facility. With its second facility – Altrun Biotechnology Development Co., in Chongqing China, also measuring at over 40,000 square feet, Alfa has a large scale combined capacity that could exceed 100MM test strips per year.
SERVICES
Alfa offers a variety of services to the medical device industry, including contract product development, technology transfer, OEM services, custom assembly and packaging with private labeling.
CAPABILITIES
Our dedicated diagnostic focus, allows us to develop accurate, consistent rapid diagnostic devices. Drawing on a dynamic team of highly skilled, talented scientists and business executives, ALFA sets itself apart from other suppliers by its ability to provide exceptional product support in the development of new technologies, novel test platforms and optimization of existing formats.
COMMITMENT
ALFA is actively involved in state-of-the-art R&D initiatives designed to keep our customers at the forefront of diagnostic technology.
ALFA has been providing unparalleled service and support to our customers by combining technical expertise, quality material and sound business strategies. We have been growing steadily to become a major supplier of rapid in-vitro diagnostic devices worldwide. Our objective is to be one of the leaders in this segment.
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