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Address: 542 Flynn Road, Camarillo, California 93012, USA
www.biosource.com |
Send Inquiry |
Phone: +1-(800)-242-0607
Annual Revenues: USD 25-50 Million
Products: Super Broth, Terrific Broth, LB Broth, Gentamicin, Pen-Strep, Liquid Bacterial Media Misc, ...
Biosource International offers a comprehensive suite of sensitive & specific elisas, luminex assays, recombinant proteins & antibodies for analysis of multiple proteins and pathways. We offer products
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Address: 4300 N. Harbor Boulevard P.O. Box 3100, Fullerton, California 92834-3100, 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
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Address: 777 Jorgensen Pl., Bellingham, Washington 98226, USA
www.kentlabs.com |
Send Inquiry |
Phone: +1-(360)-398-8641
FDA Registration: 3019906 Year Established: 1974
Annual Revenues: < USD 1 Million
Employee Count: ~10
Products: Albumin Radial Immunodiffusion Test (FDA Code:
CJQ), Protein Fractionation Immunodiffusion Test (FDA Code:
JQK), Fibrinogen Test (FDA Code:
GIS), Alpha-1-Antitrypsin (FDA Code:
DEM), Antithrombin III Control (FDA Code:
DDQ), Bence-Jones Protein (FDA Code:
CZQ), ...
Kent Laboratories, Inc. specializes in the production of polyclonal antibodies, radial immunodiffusion kits, and fluoroscein conjugated immunoglobulin fractions for manufacturers, universities & labor
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FDA Code / Regulation: DCB / 866.5520 An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).
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 the limitations in 866.9.