classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Manufacturer:

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gudid CHORUS TRIO Manufacturer: DIESSE DIAGNOSTICA SENESE SPA

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gudid CHORUS TRIO RAS Manufacturer: DIESSE DIAGNOSTICA SENESE SPA

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gudid Multiple clinical chemistry analyser IVD, laboratory, semi-automated:An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. Manufacturer: BIOTECNICA INSTRUMENTS SPA

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gudid Multiple clinical chemistry analyser IVD, laboratory, semi-automated:An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. Manufacturer: BIOTECNICA INSTRUMENTS SPA

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BK500 and BK-500 are identical device models; the difference is only the use of a hyphen Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid Maglumi 2000 Immunoassay Analyzer Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.

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gudid MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASE Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BK200 and BK-200 are identical device models; the difference is only the use of a hyphen. Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BK280 and BK-280 are identical device models; the difference is only the use of a hyphen Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BK400 and BK-400 are identical device models; the difference is only the use of a hyphen Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BK600 and BK-600 are identical device models; the difference is only the use of a hyphen Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BK1200 and BK-1200 are identical device models; the difference is only the use of a hyphen Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid BIOBASEBK200mini Manufacturer: Biobase Biodustry(Shandong)Co., Ltd.

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gudid Ion exchange chromatography analyzer sold with lithium high resolution column. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium high resolution column and autosampler. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium high performance column. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium high performance column and autosampler. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium accelerated column. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer sold with lithium accelerated column and autosampler. Manufacturer: BIOCHROM LIMITED

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gudid Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software Manufacturer: BIOCHROM LIMITED

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gudid QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates. Manufacturer: INOVA DIAGNOSTICS, INC.

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gudid QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates. Manufacturer: INOVA DIAGNOSTICS, INC.

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gudid QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates. Manufacturer: INOVA DIAGNOSTICS, INC.

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gudid The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware. Manufacturer: SENTINEL CH. SPA

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gudid The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware. Manufacturer: SENTINEL CH. SPA

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gudid Automatic Biochemistry Analyzer Manufacturer: Contec Medical Systems Co., Ltd.

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gudid Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid System liquid concentrate Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Device Qualification Test Kit EUROLabWorkstation IFA Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Device Qualification Test Kit EUROLabWorkstation ELISA Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Device Qualification Test Kit EUROLabLiquidHandler Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid EUROLabWorkstation ELISA Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid EUROBlotOne Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Sprinter XL (model 160 samples, IFA/ELISA) Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Sprinter XL (model 160 samples, IFA/ELISA incl. Incubator) Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Sprinter XL (model 240 samples, IFA/ELISA) Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Sprinter XL (model 240 samples, IFA/ELISA incl. Incubator) Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid System Qualification Test Kit Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid System liquid concentrate Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid IF Sprinter (model IFA/ELISA with ReSa-Trax) Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid IF Sprinter (model IFA/ELISA) Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid EUROIMMUN Analyzer I-2P Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Pipettor Validation Test Kit Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid EUROIMMUN Analyzer I Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG

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gudid Dimension Vista ACLN Flex reagent cartridge, 4 Flex reagent cartridges per carton Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Dimension EXL 200 System Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid CHK Flex reagent cartridge, 8 Flex reagent cartridges Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid CHK Flex reagent cartridge, 4 Flex reagent cartridge Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Dimension EXL with LM system Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Small Sample Container (SSC), 1000 Pieces Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Dimension Vista Barcode Labels Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Sample Probe Cleaner, 2x2.4 L Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Reagent Probe Cleaner, 2x2.4 L Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Cuvette wash solution, 2 x 2.4 L Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Dimension Vista System Diluent, 2x1.5 L Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Empty Vials Kit, 357 Vials, 375 Caps, 3 X 550 Labels Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid LOCI Reaction Vessel, 1000 Pieces Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Cuvettes, 20x240 (4800) Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Aliquot Plates, 30x12 (360) Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid EMPTY Flex reagent cartridge, 4 Flex reagent cartridges Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Chemistry Wash, 1x1.7 L Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Calcium Flex reagent cartridge, 480 tests Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Cuvette Cartridge - Dimension - 1 Cartridge Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid QuikLYTE Integrated Multisensor Standard B, 3x300mL Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid QuikLYTE Integrated Multisensor Standard A, 3x1 Liter Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Dimension Heterogenous Immunoassay Module - Reaction Vessels (1000) and Waste Container Liners (5) Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Sample Probe Cleaner, 1x1 Liter Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Reagent Probe Cleaner, 1x500mL Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Small Sample Container (SSC) - Dimension - 1000 Pieces Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Sample Cups - Dimension and Dimension Vista - 1000 X1.5 mL Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid EMPTY Flex reagent cartridge, 8 Flex Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Enzyme Verifier, 2x3x2mL Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Aliquot Wheel Assembly - Dimension - 8 wheels and lids Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Salt Bridge Solution, 3x150mL Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid Purified Water Diluent, 3.5 Liter Manufacturer: Siemens Healthcare Diagnostics Inc.

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gudid URIGHT Hemoglobin A1c Analyzer Manufacturer: TAIDOC TECHNOLOGY CORPORATION

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gudid MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. MyeLyte Touch with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, MyeLyte Touch with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. Manufacturer: TOKYO BOEKI MEDISYS INC.

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gudid DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. DZ-Lite c270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, DZ-Lite c270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. Manufacturer: TOKYO BOEKI MEDISYS INC.

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gudid IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. IMMTOX 270 with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, IMMTOX 270 with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. Manufacturer: TOKYO BOEKI MEDISYS INC.

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gudid BIOLIS 50i Superior is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. BIOLIS 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. Manufacturer: TOKYO BOEKI MEDISYS INC.

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gudid Biolis 24i Premium is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. Biolis 24i Premium with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 24i Premium with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. Manufacturer: TOKYO BOEKI MEDISYS INC.

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gudid BIOLIS 30i is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. BIOLIS 30i with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 30i with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry. Manufacturer: TOKYO BOEKI MEDISYS INC.

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gudid Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 Manufacturer: TOSOH CORPORATION

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gudid Auto-Prep Unit for AIA-CL1200 Manufacturer: TOSOH CORPORATION

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gudid Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200 Manufacturer: TOSOH CORPORATION

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gudid Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200 Manufacturer: TOSOH CORPORATION

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gudid Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400 Manufacturer: TOSOH CORPORATION

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FDA Product Code: JJE