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Control Antiserum Antigen Lactic Dehydrogenase Test Suppliers

  1 suppliers  
Beckman Coulter, Inc. | Address: 4300 N. Harbor Boulevard P.O. Box 3100, Fullerton, California 92834-3100, USA USA
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012  Year Established: 1934  Annual Revenues: > USD 1 Billion  Employee Count: ~10100  Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Hematology Analyzers, Blood Analyzer Reagents, Chemistry Analyzers, Controls for Diagnostic Equipment, Hematology Reagents, General Diagnostic Supplies, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic more...
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  1 Control Antiserum Antigen Lactic Dehydrogenase Test suppliers  
FDA Code / Regulation: DET / 866.5560

A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

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