Automated Urinalysis System Suppliers
Limit companies to: Worldwide USA
Roche Corporate | Address: Grenzacherstrasse 124, Basel CH-4070, Switzerland
www.roche.ch | Send Inquiry | Phone: +41-(61)-688-1111
Products: Blood Glucose Meters, POC Coagulation Analyzers (PT and INR), Alpha Fetoprotein (AFP), Hypnotics & Sedatives, Blood Glucose Monitoring Systems, Blood Glucose Monitoring Systems, ...
Roche Corporate discovers, manufactures & markets healthcare solutions. We focus on pharmaceuticals and diagnostics. Our cobas integra 400 plus is a bench top analyzer for laboratories with small to m more...
www.roche.ch | Send Inquiry | Phone: +41-(61)-688-1111
Products: Blood Glucose Meters, POC Coagulation Analyzers (PT and INR), Alpha Fetoprotein (AFP), Hypnotics & Sedatives, Blood Glucose Monitoring Systems, Blood Glucose Monitoring Systems, ...
Roche Corporate discovers, manufactures & markets healthcare solutions. We focus on pharmaceuticals and diagnostics. Our cobas integra 400 plus is a bench top analyzer for laboratories with small to m more...
HemoCue AB | Address: Box 1204, Angelholm 26223, Sweden
www.hemocue.se | Send Inquiry | Phone: +46-(77)-5700210
FDA Registration: 3003044483 Annual Revenues: USD 1-5 Million Employee Count: ~150
Products: Glucose Analyzers, Automated Urinalysis System (FDA Code: KQO), Discrete Photometric Chemistry Analyzer (FDA Code: JJE), Glucose Oxidase, Glucose (FDA Code: CGA), Automated Hemoglobin System (FDA Code: GKR), Whole Blood Hemoglobin Determination Test (FDA Code: KHG), ...
HemoCue AB develops, produces and markets medical diagnostic products. Our products are applied to perform blood and urine tests. Our product range includes HemoCue glucose systems, plasma/low Hb syst more...
www.hemocue.se | Send Inquiry | Phone: +46-(77)-5700210
FDA Registration: 3003044483 Annual Revenues: USD 1-5 Million Employee Count: ~150
Products: Glucose Analyzers, Automated Urinalysis System (FDA Code: KQO), Discrete Photometric Chemistry Analyzer (FDA Code: JJE), Glucose Oxidase, Glucose (FDA Code: CGA), Automated Hemoglobin System (FDA Code: GKR), Whole Blood Hemoglobin Determination Test (FDA Code: KHG), ...
HemoCue AB develops, produces and markets medical diagnostic products. Our products are applied to perform blood and urine tests. Our product range includes HemoCue glucose systems, plasma/low Hb syst more...
Chungdo Pharm. Co. Ltd. | Address: 202 Hi-Techventure Town, 198-53 Hupyeong-Dong, Chuncheon 200-161, Korea, Republic Of 
FDA Registration: 3007301207
Products: Automated Urinalysis System (FDA Code: KQO), Osmolality Of Serum & Urine Vapor Pressure (FDA Code: JNA), Urine Leukocyte Test (FDA Code: LJX), ...
Chungdo Pharm. Co.,Ltd. provides automated urinalysis system, urine leukocyte test, urine test reagent strips and various other medical accessories. more...
FDA Registration: 3007301207
Products: Automated Urinalysis System (FDA Code: KQO), Osmolality Of Serum & Urine Vapor Pressure (FDA Code: JNA), Urine Leukocyte Test (FDA Code: LJX), ...
Chungdo Pharm. Co.,Ltd. provides automated urinalysis system, urine leukocyte test, urine test reagent strips and various other medical accessories. more...
YD Diagnostics Corp. | Address: No. 173, Seo-Ri, Yidong-Myun, Choin-Gu, Yongin-Si 449-834, Korea, Republic Of
www.yd-diagnostics.com | Send Inquiry | Phone: +82-(31)-329-2000
FDA Registration: 9710094
Products: Automated Urinalysis System (FDA Code: KQO), Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Enzymatic Method (FDA Code: JIL), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Occult Blood in Urine Test (FDA Code: JIO), ...
YD Diagnostics Corp. specializes in the manufacture of IVD products. We manufacture various IVD products including diabetes products, immunodiagnostics, molecular biology products and analyzers. UriSc more...
www.yd-diagnostics.com | Send Inquiry | Phone: +82-(31)-329-2000
FDA Registration: 9710094
Products: Automated Urinalysis System (FDA Code: KQO), Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Enzymatic Method (FDA Code: JIL), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Occult Blood in Urine Test (FDA Code: JIO), ...
YD Diagnostics Corp. specializes in the manufacture of IVD products. We manufacture various IVD products including diabetes products, immunodiagnostics, molecular biology products and analyzers. UriSc more...
Hitachi Science Systems, Ltd. | Address: 1040 Ichige, Hitachinaka 312-0033, Japan
Phone: +81-(29)-271265
Products: Automated Urinalysis System (FDA Code: KQO), Discrete Photometric Chemistry Analyzer (FDA Code: JJE), ...
Hitachi Science Systems, Ltd. focuses on clinical testing systems. more...
Phone: +81-(29)-271265
Products: Automated Urinalysis System (FDA Code: KQO), Discrete Photometric Chemistry Analyzer (FDA Code: JJE), ...
Hitachi Science Systems, Ltd. focuses on clinical testing systems. more...
Sysmex Corporation | Address: 4-4-4, Takatsukadai, Nishi-ku, Kobe 651-2271, Japan
www.sysmex.co.jp | Send Inquiry | Phone: +81-(078)-991-1911
FDA Registration: 9613959 Year Established: 1968
Products: Coagulation Analyzers (FDA Code: GKP), Electronic Medical Records Software, Anticoagulation Therapy Monitoring, Automated Coagulation Analyzer (FDA Code: GKP), Fully Automated Random Access Coagulation Analyzer, Automated Urinalysis System (FDA Code: KQO), ...
Sysmex Corporation provides medical solutions for hospitals and clinical laboratories. We focus on scientific support and particle analyser. Our Sysmex FPIA-3000 flow particle image analyzer offers re more...
www.sysmex.co.jp | Send Inquiry | Phone: +81-(078)-991-1911
FDA Registration: 9613959 Year Established: 1968
Products: Coagulation Analyzers (FDA Code: GKP), Electronic Medical Records Software, Anticoagulation Therapy Monitoring, Automated Coagulation Analyzer (FDA Code: GKP), Fully Automated Random Access Coagulation Analyzer, Automated Urinalysis System (FDA Code: KQO), ...
Sysmex Corporation provides medical solutions for hospitals and clinical laboratories. We focus on scientific support and particle analyser. Our Sysmex FPIA-3000 flow particle image analyzer offers re more...
Hitachi High-Technologies Corporation (Instruments Group) | Address: 24-14,Nishi-Shimbashi 1-chome,Minato-ku, Tokyo 105-8717, Japan
www.hitachi-hitec.com | Phone: +81-(3)-3504-7111
FDA Registration: 9614673
Products: Automated Urinalysis System (FDA Code: KQO), Discrete Photometric Chemistry Analyzer (FDA Code: JJE), ...
Hitachi High-Technologies Corporation (Instruments Group) produces UV/visible/NIR spectrophotometers, liquid chromatograph mass spectrometers, clinical analyzers, potentiometric titrators and mercury more...
www.hitachi-hitec.com | Phone: +81-(3)-3504-7111
FDA Registration: 9614673
Products: Automated Urinalysis System (FDA Code: KQO), Discrete Photometric Chemistry Analyzer (FDA Code: JJE), ...
Hitachi High-Technologies Corporation (Instruments Group) produces UV/visible/NIR spectrophotometers, liquid chromatograph mass spectrometers, clinical analyzers, potentiometric titrators and mercury more...
Macherey-Nagel Gmbh & Co., Kg. | Address: Neumann-Neander-Strasse 6-8, Dueren 52355, Germany 
www.mn-net.com | Send Inquiry | Phone: +49-(242)-1-969-0
FDA Registration: 4580 Quality: ISO 9001:2008, ISO 13485:2003 Certified
Products: Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Enzymatic Method (FDA Code: JIL), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Urinary Occult Blood Enzymatic Method (FDA Code: JIP), ...
Macherey-Nagel Gmbh & Co., Kg. specializes in medical diagnosis, chromatography and bioanalysis. The use of urine test strips is acknowledged as a modern screening method in medical practice. This non more...
www.mn-net.com | Send Inquiry | Phone: +49-(242)-1-969-0
FDA Registration: 4580 Quality: ISO 9001:2008, ISO 13485:2003 Certified
Products: Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Enzymatic Method (FDA Code: JIL), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Urinary Occult Blood Enzymatic Method (FDA Code: JIP), ...
Macherey-Nagel Gmbh & Co., Kg. specializes in medical diagnosis, chromatography and bioanalysis. The use of urine test strips is acknowledged as a modern screening method in medical practice. This non more...
Analyticon Biotechnologies Ag | Address: Am Muehlenberg 10, Lichtenfels 35104, Germany
www.analyticon-diagnostics.com | Send Inquiry | Phone: +49-(64)-547-991
FDA Registration: 3003775076
Products: Automated Urinalysis System (FDA Code: KQO), Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Enzymatic Method (FDA Code: JIL), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Urinary Nitrite Colorimetric Test (FDA Code: JMT), ...
Analyticon Biotechnologies Ag manufactures diagnostic systems. Our clinical products include analyzer, urinalysis, clinical chemistry, rapid slide tests and diabetes products. Our analyzers comprise o more...
www.analyticon-diagnostics.com | Send Inquiry | Phone: +49-(64)-547-991
FDA Registration: 3003775076
Products: Automated Urinalysis System (FDA Code: KQO), Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Enzymatic Method (FDA Code: JIL), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Urinary Nitrite Colorimetric Test (FDA Code: JMT), ...
Analyticon Biotechnologies Ag manufactures diagnostic systems. Our clinical products include analyzer, urinalysis, clinical chemistry, rapid slide tests and diabetes products. Our analyzers comprise o more...
Roche Diagnostics Gmbh Mannheim | Address: Sandhofer Strasse 116, Mannheim D-68305, Germany
FDA Registration: 9610529
Products: Automated Urinalysis System (FDA Code: KQO), Radioimmunoassay for Dehydroepiandrosterone Sulfate (FDA Code: JKC), Estradiol Radioimmunoassay Test (FDA Code: CHP), Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ), Hydroxyproline Chromatography Column Test (FDA Code: JMM), Total Triiodothyronine Radioimmunoassay (FDA Code: CDP), ...
Roche Diagnostics Gmbh Mannheim is a provider of automated urinalysis system and cardiac readers. more...
FDA Registration: 9610529
Products: Automated Urinalysis System (FDA Code: KQO), Radioimmunoassay for Dehydroepiandrosterone Sulfate (FDA Code: JKC), Estradiol Radioimmunoassay Test (FDA Code: CHP), Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ), Hydroxyproline Chromatography Column Test (FDA Code: JMM), Total Triiodothyronine Radioimmunoassay (FDA Code: CDP), ...
Roche Diagnostics Gmbh Mannheim is a provider of automated urinalysis system and cardiac readers. more...
Roche Diagnostics Gmbh | Address: Sandhoferstrasse 116, Mannheim D-68298, Germany
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), Solid Phase Rabbit Digoxin (125-I) Radioimmunoassay Test (FDA Code: DON), Cyclosporine and Metabolites Serum Assay (FDA Code: MAR), Cyclosporine (FDA Code: MKW), Digoxin (125-I) Radioimmunoassay (FDA Code: LCS), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products more...
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), Solid Phase Rabbit Digoxin (125-I) Radioimmunoassay Test (FDA Code: DON), Cyclosporine and Metabolites Serum Assay (FDA Code: MAR), Cyclosporine (FDA Code: MKW), Digoxin (125-I) Radioimmunoassay (FDA Code: LCS), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products more...
Lre Medical Gmbh | Address: Hofer Strasse 5, Noerdlingen 86720, Germany
FDA Registration: 3003366417
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Fluorometer for Clinical Use (FDA Code: KHO), Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH), Glucose Glucose Dehydrogenase (FDA Code: LFR), Urinary Enzymatic Method (FDA Code: JIL), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Lre Medical Gmbh offers assayed and unassayed single analyte controls, fluorometer for clinical use, automated hemoglobin systems and urinary enzymatic methods. more...
FDA Registration: 3003366417
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Fluorometer for Clinical Use (FDA Code: KHO), Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH), Glucose Glucose Dehydrogenase (FDA Code: LFR), Urinary Enzymatic Method (FDA Code: JIL), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Lre Medical Gmbh offers assayed and unassayed single analyte controls, fluorometer for clinical use, automated hemoglobin systems and urinary enzymatic methods. more...
Dirui Industrial Co., Ltd. | Address: 95 Yunhe St., New & High Tech, Development Zone, Changchun 130012, China 
www.dirui.com.cn | Send Inquiry | Phone: +86-(431)-85100409
FDA Registration: 3003741796 Quality: ISO9001, ISO13485, CE Certified
Products: Clinical Refractometer (FDA Code: JRE), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB), Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Nitrite Colorimetric Test (FDA Code: JMT), ...
Dirui Industrial Co., Ltd provides medical instruments and reagents. We are an ISO 9001, ISO 13485 and CE certified company. Our medical instruments include urine, chemistry and hematology analyzers. more...
www.dirui.com.cn | Send Inquiry | Phone: +86-(431)-85100409
FDA Registration: 3003741796 Quality: ISO9001, ISO13485, CE Certified
Products: Clinical Refractometer (FDA Code: JRE), 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB), Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Urinary Nitrite Colorimetric Test (FDA Code: JMT), ...
Dirui Industrial Co., Ltd provides medical instruments and reagents. We are an ISO 9001, ISO 13485 and CE certified company. Our medical instruments include urine, chemistry and hematology analyzers. more...
Chong Qing Teco Huayi Pharm Co. | Address: 4th Fl, No. K Standard Workshop, High-Tech Zone, Shiqiaopu District, Chong Qing, Chong Qing 40004-1, China
Phone: +86-(23)-68694387
FDA Registration: 3006621318
Products: Automated Urinalysis System (FDA Code: KQO), Clinical Colorimeter (FDA Code: JJQ), Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI), Potassium Colorimetry Tetraphenyl Borate Test (FDA Code: CEJ), ...
Chong Qing Teco Huayi Pharm Co. focuses on automated urinalysis system, clinical colorimeter, human chorionic gonadotropin radioimmunoassay and potassium colorimetry tetra phenyl borate test. more...
Phone: +86-(23)-68694387
FDA Registration: 3006621318
Products: Automated Urinalysis System (FDA Code: KQO), Clinical Colorimeter (FDA Code: JJQ), Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI), Potassium Colorimetry Tetraphenyl Borate Test (FDA Code: CEJ), ...
Chong Qing Teco Huayi Pharm Co. focuses on automated urinalysis system, clinical colorimeter, human chorionic gonadotropin radioimmunoassay and potassium colorimetry tetra phenyl borate test. more...
Acon Biotech (Hangzhou) Co., Ltd. | Address: 10125 Mesa Rim Road., San Diego 92121, China
www.aconlab.com.cn | Send Inquiry | Phone: +1-(858)-875-8000
FDA Registration: 9615507
Products: HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX), Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI), Luteinizing Hormone Radioimmunoassay (FDA Code: CEP), Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ), Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO), Streptococcus Spp Antigen (FDA Code: GTY), ...
Acon Biotech (Hangzhou) Co., Ltd. provides a broad range of rapid diagnostic and healthcare products. We offer diabetes care, immunoassay, and clinical chemistry, such as urinalysis, urine analyzer, u more...
www.aconlab.com.cn | Send Inquiry | Phone: +1-(858)-875-8000
FDA Registration: 9615507
Products: HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX), Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI), Luteinizing Hormone Radioimmunoassay (FDA Code: CEP), Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ), Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO), Streptococcus Spp Antigen (FDA Code: GTY), ...
Acon Biotech (Hangzhou) Co., Ltd. provides a broad range of rapid diagnostic and healthcare products. We offer diabetes care, immunoassay, and clinical chemistry, such as urinalysis, urine analyzer, u more...
Chong Qing Teco Huayi Pharm. Co. | Address: 4th Floor No. K Standard Workshop, High Tech Zone, Shiqiaopu District, Chongqing, CN-50 40004, China
FDA Registration: 3006621318
Products: Automated Urinalysis System (FDA Code: KQO), Cardiopulmonary Resuscitation Aid (FDA Code: LIX), Blood Gas and Ph Electrode Measurement (FDA Code: CHL), Chloride Ion Specific Electrode (FDA Code: CGZ), Clinical Colorimeter (FDA Code: JJQ), Differential Cell Counter (FDA Code: GKZ), ...
Chong Qing Teco Huayi Pharm. Co. specializes in providing urine testers. more...
FDA Registration: 3006621318
Products: Automated Urinalysis System (FDA Code: KQO), Cardiopulmonary Resuscitation Aid (FDA Code: LIX), Blood Gas and Ph Electrode Measurement (FDA Code: CHL), Chloride Ion Specific Electrode (FDA Code: CGZ), Clinical Colorimeter (FDA Code: JJQ), Differential Cell Counter (FDA Code: GKZ), ...
Chong Qing Teco Huayi Pharm. Co. specializes in providing urine testers. more...
Ind Diagnostic Inc | Address: 1629 Fosters Way, Delta, British Columbia V3M 6S7, Canada 
www.ind.ca | Send Inquiry | Phone: +1-(604)-522-1619
Products: Ovulation (Luteinizing Hormone) Test Kits, Gonorrhea Test Kits, Swabs, Gonorrhea Test Kits, Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO), Osmolality Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure (FDA Code: JMZ), Over The Counter Follicle Stimulating Hormone (Fsh) Test (FDA Code: NGA), ...
Ind Diagnostic Inc. is a biotechnology company that specializes in research, development and manufacturing of advanced in-vitro diagnostic (IVD) test systems. We are accredited with ISO9001 & ISO13485 more...
www.ind.ca | Send Inquiry | Phone: +1-(604)-522-1619
Products: Ovulation (Luteinizing Hormone) Test Kits, Gonorrhea Test Kits, Swabs, Gonorrhea Test Kits, Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO), Osmolality Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure (FDA Code: JMZ), Over The Counter Follicle Stimulating Hormone (Fsh) Test (FDA Code: NGA), ...
Ind Diagnostic Inc. is a biotechnology company that specializes in research, development and manufacturing of advanced in-vitro diagnostic (IVD) test systems. We are accredited with ISO9001 & ISO13485 more...
Btnx, Inc. | Address: 570 Hood Road, Unit 23, Markham, Ontario L3R 4G7, Canada
www.btnx.com | Phone: +1-(905)-9449565, 888 339 9964
FDA Registration: 3003917514 Quality: ISO 13485, ISO 9001 Certified
Products: Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Occult Blood Reagent (FDA Code: KHE), Osmolality Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure (FDA Code: JMZ), Over The Counter Follicle Stimulating Hormone (Fsh) Test (FDA Code: NGA), Morphine Thin Layer Chromatography (FDA Code: DNK), ...
Btnx, Inc. is a biotechnology company. We provide rapid, point-of-care diagnostics. We develop and manufacture advanced in-vitro diagnostic (IVD) tests and information technology systems to manage poi more...
www.btnx.com | Phone: +1-(905)-9449565, 888 339 9964
FDA Registration: 3003917514 Quality: ISO 13485, ISO 9001 Certified
Products: Non-Quantitative Urobilinogen Test (FDA Code: CDM), Urinary pH Dye Indicator (FDA Code: CEN), Occult Blood Reagent (FDA Code: KHE), Osmolality Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure (FDA Code: JMZ), Over The Counter Follicle Stimulating Hormone (Fsh) Test (FDA Code: NGA), Morphine Thin Layer Chromatography (FDA Code: DNK), ...
Btnx, Inc. is a biotechnology company. We provide rapid, point-of-care diagnostics. We develop and manufacture advanced in-vitro diagnostic (IVD) tests and information technology systems to manage poi more...
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FDA Code / Regulation: KQO / 862.2900
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.
