Genzyme Diagnostics

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Web: http://www.genzymediagnostics.com
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Address: One Kendall Square, Cambridge, Massachusetts 02139-1562, USA
Phone: +1-(508)-661-1835 | Map/Directions >>
 
 

Profile: Genzyme Diagnostics offers a unique product portfolio for diagnostic manufacturers and clinical laboratories. Our product OSOM® Mono is ideal for the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis. We offer OSOM® hCG urine which is ideal for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. Our OSOM® Ultra Strep A is a color iimmunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. The OSOM® ImmunoDip® urinary albumin test detects the presence of elevated levels of albumin in urine to aid in the diagnosis of microalbuminuria. Our product OSOM® card pregnancy is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early determination of pregnancy.

FDA Registration Number: 2030538

31 Products/Services (Click for related suppliers)  
• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660)
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
• Culture Media Quality Control Kit (FDA Code: JTR / 866.2480)
A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
• Diagnostic Test Kits For Pregnancy
• Early Pregnancy Testing Kit
• General Diagnostic Supplies
• General Medical Supplies
• Giardia Spp. (FDA Code: MHI / 866.3220)
• HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX / 862.1155)
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.
• HDL Cholesterol Calibrator
• HDL Linearity Verifiers
• Home pregnancy test kits, Hcg
• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)
• Immunoassay Reagents & Test Kits
• Infectious Disease Exams
• Infectious Disease Identification Test Kits
• Infectious Disease Test Kits
• Infectious Disease Testing Viral Quality Control kits
• Infectious Mononucleosis Test System (FDA Code: KTN / 866.5640)
An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.
• Influenza Virus CF Antigen (FDA Code: GNX / 866.3330)
Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.
• LDL Cholesterol Calibrator
• LDL Cholesterol Linearity Verifiers
• Lipoproteins Microdensitometry Method Test (FDA Code: JHL / 862.1475)
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Microbiology Kit
• Pregnancy Kits
• Pregnancy Testing Kits
• Quality Control Kits (FDA Code: JTR / 866.2480)
• Sensitive Pregnancy Tests
• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740)
• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740)
• Trichomonas Screening Kit (FDA Code: JWZ / 866.2660)
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
• Water-microbiology kit

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