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Address: 6392 Via Real, Carpinteria, California 93013, USA
www.dakousa.com |
Send Inquiry |
Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million
Employee Count: ~180
Quality: ISO 9001 Certified
Products: Albumin Antigen Antiserum Control (FDA Code:
DCF), Albumin, FITC Conjugate (FDA Code:
DDZ), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code:
GQO), 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code:
GQL), Acid Fuchsin Stain (FDA Code:
IDF), Alcian Blue Stain (FDA Code:
IDA), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen
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Address: 5889 Oberlin Dr, #101, San Diego, California 92121, USA
www.bindingsite.co.uk |
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Phone: +1-(800)-633-4484
FDA Registration: 2083566 Year Established: 1988
Employee Count: ~60
Quality: ISO 9001, ISO 9002, CE Certified
Products: Diagnostic Devices, Infectious Diseases Assays, Immunofluorescence Assay Reagents, Albumin Radial Immunodiffusion Test (FDA Code:
CJQ), Lipoproteins Radial Immunodiffusion Test (FDA Code:
JHP), Enzyme Immunoassay, ...
The Binding Site manufactures immunodiagnostic assays in the fields of autoimmune disease and multiple myeloma. We offer autoimmune diagnostics, infectious diseases and radial immunodiffusion. We spec
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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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Address: Via Crescentino Snc., Saluggia (VC) 13040, Italy
www.diasorin.com |
Send Inquiry |
Phone: +39-(161)-487-526
FDA Registration: 9616669 Annual Revenues: USD 50-100 Million
Quality: ISO 9001, CE Certified
Products: Adult Vaccines, Calibrators, Chemistry Analyzers, Immunoassay Analyzers, General Diagnostic Supplies, General Medical Supplies, ...
DiaSorin S.p.A. creates & manufactures reagents for in vitro diagnostics. Our products are available in RIA, elisa and Liaison® formats that include markers for breast, ovarian, colorectal, stomac
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FDA Code / Regulation: JZH / 866.5320 A properdin factor B immunological test system is a device that consists of the reagents used to measure by immunochemical techniques properdin factor B in serum and other body fluids. The deposition of properdin factor B in body tissues or a corresponding depression in the amount of properdin factor B in serum and other body fluids is evidence of the involvement of the alternative to the classical pathway of activation of complement (a group of plasma proteins which cause the destruction of cells which are foreign to the body). Measurement of properdin factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermititis herpetiformis (presence of vesicles on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other diseases in which the alternate pathway of complement activation has been implicated include rheumatoid arthritis, sickle cell anemia, and gram-negative bacteremia.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.