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ISO 13485: 2003


Certificate of Registration

ISO 13485: 2016





Cenogenics Corporation, and its wholly owned subsidiary Laboratory Diagnostics Company, have specialized in the manufacture, distribution and contract manufacturing of in-vitro diagnostic tests since 1981.  The company’s manufacturing expertise includes the impregnation of high quality papers for various diagnostic and industrial purposes.  A principal product which embodies the company’s impregnation technology is the Stool Blood Test used world-wide to screen for colo-rectal cancer.  The company has used its paper impregnation methods, in addition to medical applications, to produce an end-tidal Carbon Dioxide monitor used to determine the proper placement of an endotracheal tube for a sensor manufacturer, a test to determine degradation of deep-fry cooking oils for a major food group and a test system to detect leaks in aircraft weld seams for a commercial airline manufacturer.

The company manufactures and distributes immunodiagnostic test systems for syphilis, C-Reactive Protein, Rheumatoid Factor, infectious mononucleosis, febrile antigens, Brucella Rose Bengal Antigen, rapid one-step tests for pregnancy and ovulation and tests for other diseases.  The company contract manufactures diagnostic tests and bulk reagents for other manufacturers in fifteen countries.  Contract manufacturing services also include packaging, filling and compounding.

The company holds newly issued patents which increase the sensitivity and specificity of immunodiagnostic procedures.  A new Lyme disease test based on the patent principals has provided a reliable and sensitive diagnostic system for early diagnosis and will be released following conclusion of clinical trials and regulatory submissions.  The patent applications also have use in vaccine production and other uses.  The company would be pleased to license its patents and know-how.  All business proposals will be seriously considered.


The company’s line of diagnostic products are distributed in 60 countries.  The company’s ability to provide competitive pricing, FDA registered product and attentive service led to being honored with the United States National Exporter of the Year Award in 1990.

Cenogenics Corporation is registered to ISO 13485:2016.  The company and its products are fully FDA registered and comply with EU and CE requirements. 


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