Wako Diagnostics

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Web: http://www.wakousa.com
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Address: 1600 Bellwood Road, Richmond, Virginia 23237, USA
Phone: +1-(804)-714-1924 | Fax: +1-(804)-271-0449 | Map/Directions >>

Profile: Wako Diagnostics develops high purity chemicals. We are an ISO 9001 certified company. We are a comprehensive manufacturer of clinical diagnostic reagents that are of highest quality and extremely cost competitive. Our autokit micro albumin test kit helps in the quantitative determination of micro albumin in human urine. We deliver functionalized water-soluble azo initiators for emulsion polymerization system. Our Limusate® is a chloroform-extracted product & the reaction is performed optimally in either soda-lime or borosilicate glass tubes.

The company was founded in 1981, has revenues of USD 5-10 Million, has ~60 employees and is ISO 9001 certified.

FDA Registration Number: 1627434

41 Products/Services (Click for related suppliers)

• Alpha Fetoprotein L3 Subfraction (Afp-L3%) Test For Hepatocellular Carcinoma Risk Assessment (FDA Code: NSF / 866.6030)

• 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.

• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110)

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

• Bilirubin Enzymatic Method Test (FDA Code: JFM / 862.1110)

• Bilirubinometer

• C-Reactive Protein (CRP)

• Cancer Test Kits

• Cardiac Markers kits

• Cholesterol Colorimetric Test (FDA Code: CGO / 862.1175)

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

• Complement C9 (FDA Code: DAE / 866.5240)

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Creatinine Enzymatic Method Test (FDA Code: JFY / 862.1225)

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

• Detergent (FDA Code: JCB / 864.4010)

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160)

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Fatty Acids Titrimetric (FDA Code: JLH / 862.1290)

A fatty acids test system is a device intended to measure fatty acids in plasma and serum. Measurements of fatty acids are used in the diagnosis and treatment of various disorders of lipid metabolism.

• General Chemistry Calibrators

• General Chemistry Kits

• General Chemistry Test Kits

• Glucose Hexokinase Test (FDA Code: CFR / 862.1345)

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470)

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• HDL Precipitation Method (FDA Code: LBR / 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.

• Hepatocellular Carcinoma Risk Assessment, Des-Gamma-Carboxy-Prothrombin (Dcp) (FDA Code: OAU / 866.6030)

• Immunoassay Reagents & Test Kits

• Immunoassays

• Instruments, Immunoassays

• Isotonic Solution (FDA Code: JCE / 864.4010)

• LDL & VLDL Precipitation Method (FDA Code: LBR / 862.1475)

• LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase (FDA Code: LBS / 862.1475)

• Lipids Test Kits

• Lipoprotein Low-Density Test System (FDA Code: MRR / 862.1475)

• Lipoprotein(A) Test System (FDA Code: MSM / 862.1475)

• Lipoproteins Turbidimetric Method Test (FDA Code: JHN / 862.1475)

• Low Density Lipoprotein (FDA Code: DFC / 866.5600)

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150)

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Primary Calibrator (FDA Code: JIS / 862.1150)

• Protein /Albumin Turbidimetric Method (FDA Code: JIQ / 862.1645)

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Reference Testing Facilities

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• Test Kits, Lipids

• Total Protein Biuret Method (FDA Code: CEK / 862.1635)

A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

• Total Protein Turbidimetric Test (FDA Code: JGQ / 862.1635)

• Triglycerides Lipase Hydrolysis/Glycerol Kinase Enzyme Test (FDA Code: CDT / 862.1705)

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.