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Address: 510 Furnace Dock Road, Cortlandt Manor, New York 10567, USA
www.polymedco.com |
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Phone: +1-(914)-739-5400
FDA Registration: 2435505 Year Established: 1980
Annual Revenues: USD 10-25 Million
Employee Count: ~50
Products: Hematology Analyzers, Erythrocyte Sedimentation Rate (ESR) Test Kits, Bladder Tumor Antigen (NMP22) Test Kits, Streptococcus Test Kits, Bladder Cancer Tests, Chemistry Analyzers, ...
Polymedco Inc. introduced a magnetic separation method for HDL which is better than the conventional testing means for cholesterol. We introduced Sed-Chek® 2 ESR control which helps in sedrate con
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Address: 5440 Patrick Henry Dr., Santa Clara, California 95054, USA
www.abbott.us |
Phone: +1-(408)-982-4800
FDA Registration: 2919069 Employee Count: ~72000
Quality: ISO 9001, CE Certified
Products: Diagnostic Instruments, Diagnostic Test Kits, Medical Devices, Coronary Guide Wires, Topical Hemostasis Pad, Suture Trimmer, ...
Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a
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Address: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, USA
www.abbott.com |
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Phone: +1-(847)-937-6100
FDA Registration: 1451914 Employee Count: ~5000
Products: Anesthesia Equipment, Bladder Cancer Tests, Analgesics, Anesthetics, Cardiovasculars, Controls, ...
Abbott Laboratories is a diversified health care company which discovers, develops, manufactures and markets innovative products & services that span the continuum of care from prevention, diagnosis t
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Address: El Mercurio E10-51 Y La Razon, Quito, Pichincha 0000, Ecuador
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Phone: +593-(2)-246-6980
Year Established: 1985
Annual Revenues: USD 1-5 Million
Employee Count: ~40
Products: Allergy Testing, Elisa Allergy test Kit, Latex Allergy Test Kit, Home Allergy Test Kit, Product Development, Allergy Test Strips, Allergy Test, ...
Simed Cia. Ltda. supplies calibration reagent, Elisa allergy test kit, microbiology diagnostic device, home allergy test kit, and blood tumor marker monitoring test kit.
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FDA Code / Regulation: MMW / 866.6010 A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.