Denka Seiken Co., Ltd (kagamida Facility)

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Contact: Yoshio Noda
Web: http://www.denka-seiken.co.jp
E-Mail:
Address: 3-4-2, Nihonbashi,Kayabacho,Chuo-ku, Tokyo 103-0025, Japan
Phone: +81-(3)-3669-9421 | Fax: +81-(3)-3669-9390 | Map/Directions >>

Profile: Denka Seiken Co,.Ltd.{kagamida facility} specializes in bacteriology and virology, immunochemistry, clinical chemistry and food-related diagnostic reagents. Our bacteriology products comprise of staphylococcus aureus, escherichia coli, streptococci, salmonella, shigella and vibrio. Receptor destroying enzyme(RDE) is used to eliminate inhibitors of nonspecific hemagglutination in human sera when performing the Hemagglutination Inhibition(HI) test. The product is a filter-sterilized, lyophilized culture supernatant of Vibrio cholerae Ogawa type 558. The product is packaged at 20 mL x 5 vials, and used at serum:RDE ratio of 1:3. we provide diagnostic reagent that offers antigen-antibody reactions to determine the quantity of serum proteins in the blood. These are latex reagents that utilize latex agglutination and turbidimetric immunodiagnostic assay reagents that directly measure agglutination by antigen-antibody reaction.

FDA Registration Number: 3003871639
US Agent: Sheila W. Pickering
Phone: +1-(650)-279-0668 E-Mail:

32 Products/Services (Click for related suppliers)

• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720)

• 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.

• B. Parapertussis Agglutinating Antisera (FDA Code: GOW / 866.3065)

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270)

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• C-Reactive Protein Test System (FDA Code: DCN / 866.5270)

• Diphenylhydantoin Enzyme Immunoassay Test (FDA Code: DIP / 862.3350)

A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

• Diphenylhydantoin Fluorescence Polarization Immunoassay (FDA Code: LGR / 862.3350)

• Drug Specific Calibrator (FDA Code: DLJ / 862.3200)

A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

• Escherichia Coli Antisera (FDA Code: GNA / 866.3255)

• Flavobacterium Meningosepticum Antiserum (FDA Code: GSW / 866.3270)

• Haemophilus Influenza Antiserum (FDA Code: GRP / 866.3300)

• Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP / 862.1405)

An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

• Klebsiella Spp Antiserum (FDA Code: GTC / 866.3340)

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

• Legionella DNA Reagents (FDA Code: LQH / 866.3300)

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

• Listeria Monocytogenes Antisera (FDA Code: GSH / 866.3355)

• 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.

• Phenobarbital Enzyme Immunoassay Test (FDA Code: DLZ / 862.3660)

A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

• Primary Calibrator (FDA Code: JIS / 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.)

• Pseudomonas Pseudomallei Antiserum (FDA Code: GST / 866.3415)

• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550)

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• Serratia Marcescens Antisera (FDA Code: GTA / 866.3630)

• Shigella Spp Antigen (FDA Code: LIA / 866.3660)

• Shigella Spp Antiserum (FDA Code: GNB / 866.3660)

• Staphylococcus Colonies Resistant Markers, Genotypic Detection Test System (FDA Code: MYI / 866.1640)

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

• Staphylococcus Spp Fluorescent Antisera (All Types) (FDA Code: GTN / 866.3700)

• Streptococcus Pneumoniae Antisera (FDA Code: GWC / 866.3740)

• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740)

• Valproic Acid Enzyme Immunoassay Test (FDA Code: LEG / 862.3645)

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

• Vibrio Cholerae Antiserum (FDA Code: GSQ / 866.3930)