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Address: 101 Hartwell Avenue, Lexington, Massachusetts 02421-3125, USA
www.ilus.com |
Send Inquiry |
Phone: +1-(781)-861-0710
FDA Registration: 1217183 Year Established: 1959
Annual Revenues: USD 50-100 Million
Employee Count: ~300
Products: Blood Gas Analyzers, Automated Coagulation Analyzer (FDA Code:
GKP), Blood Gas/pH analyzer, Electrolyte Chemistry Analyzer, Toxicology Lithium Flame Photometer, Automated Coagulation Timer, ...
Instrumentation Laboratory (IL) manufactures and supplies critical care diagnostic & hemostasis instruments. We offer products like haemostatisis diagnostics, critical care diagnostics & acc trak. In
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Address: Can Male s-n, Lliçà d'Amunt, Barcelona 08186, Spain
www.biokit.com |
Send Inquiry |
Phone: +34-(93)-860-9000
Annual Revenues: USD 10-25 Million
Employee Count: ~120
Quality: ISO 9001 Certified
Products: Syphilis - Rapid Plasma Reagin (RPR), Rapid Plasma Reagin (RPR) Test Kits, ELISA Microtiter Plate Immunoanalyzer, Automated Microtiter Plate ELISA Reader, C-Reactive Protein Test System (FDA Code:
DCN), Infectious Mononucleosis Test System (FDA Code:
KTN), ...
Biokit manufactures and distributes clinical diagnostic reagents. We are certified with ISO 9001. We offer products like rapid test, bioelisa, quantex, instrumentation, raw materials & catalogues PDF.
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Address: 125 Avenue Louis Roche, Gennevilliers 92230, France
Phone: 33-146-88 20
Products: Histidine Chromatographic Test (FDA Code:
JMI), Platelet Control (FDA Code:
GJP), Qualitative and Quantitative Factor Deficiency Test (FDA Code:
GGP), Alpha-2-Glycoproteins (FDA Code:
DEJ), Antithrombin III Control (FDA Code:
DDQ), Beta 2-Glycoprotein I (FDA Code:
DDN), ...
Serbio deals with the standardization of immunoassays for antiphospholipid antibodies.
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Address: 1395 Sandhill Dr., Ancaster, Ontario L9G 4V5, Canada
www.affinitybiologicals.com |
Send Inquiry |
Phone: +1-(905)-304-9896
FDA Registration: 3003485232 Year Established: 1987
Annual Revenues: USD 1-5 Million
Employee Count: ~20
Quality: ISO 13485:2003 Certified
Products: Analyte Specific Reagents, Asr Reagents (FDA Code:
MVU), Multi Analyte Mixture - Calibrator (FDA Code:
JIX), Enzyme Immunoassay, Abnormal Plasma Control (FDA Code:
GGC), Plasma Coagulation Control (FDA Code:
GGN), Qualitative and Quantitative Factor Deficiency Test (FDA Code:
GGP), ...
Affinity Biologicals, Inc. is a manufacturer of products used in thrombosis and haemostasis research and medical diagnostics. Products include an extensive line of antibodies, conjugates, antibody pai
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FDA Code / Regulation: DBT / 866.5330 A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.
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. This exemption does not apply to factor deficiency tests classified under 864.7290 of this chapter.