Assayed and Unassayed Single (Specified) Analyte Controls Suppliers
Limit companies to: Worldwide USA
AgaMatrix, Inc. | Address: 10 Manor Parkway, Salem, New Hampshire 03079, USA 
www.agamatrix.com | Send Inquiry | Phone: +1-(603)-328-6000/866-906-4197
FDA Registration: 3004637226
Products: Blood Glucose Monitoring Systems, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Blood Glucose Data Management Systems, ...
AgaMatrix, Inc. develops and manufactures a line of diabetes products, which are designed to improve the quality of diabetes care. Our WaveSense technology personalizes each test to provide accuracy. more...
www.agamatrix.com | Send Inquiry | Phone: +1-(603)-328-6000/866-906-4197
FDA Registration: 3004637226
Products: Blood Glucose Monitoring Systems, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Blood Glucose Data Management Systems, ...
AgaMatrix, Inc. develops and manufactures a line of diabetes products, which are designed to improve the quality of diabetes care. Our WaveSense technology personalizes each test to provide accuracy. more...
Gb Daily Care Corporation | Address: 8 Golden Pond Dr, Milltown, New Jersey 08850, USA
www.gbdailycare.com
Products: ECG Machine, Diagnostic Instruments, Blood Pressure Apparatus, EKG Machines, Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Electrocardiograph (FDA Code: DPS), ...
Gb Daily Care Corporation specializes in rollators and walkers. Our product line includes lift chairs, power wheelchairs, mobility scooters, manualwheel chairs, foldable ramps and vehicle lifts. Our p more...
www.gbdailycare.com
Products: ECG Machine, Diagnostic Instruments, Blood Pressure Apparatus, EKG Machines, Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Electrocardiograph (FDA Code: DPS), ...
Gb Daily Care Corporation specializes in rollators and walkers. Our product line includes lift chairs, power wheelchairs, mobility scooters, manualwheel chairs, foldable ramps and vehicle lifts. Our p more...
Alfa Wasserman Inc. | Address: 4 Henderson Drive, West Caldwell, New Jersey 07006, USA
www.alfawassermannus.com | Send Inquiry | Phone: +001-(800)-220-4488
FDA Registration: 2247288 Year Established: 1960 Annual Revenues: USD 10-25 Million Employee Count: ~160 Quality: ISO 9001, CE Certified
Products: Scrubs, Ferritin (FDA Code: DBF), Blood Analyzer Reagents, Calibrators for Equipment, Chemistry Analyzers, Glass & Plastic Bottles, ...
Alfa Wasserman Inc provides reliable & fully integrated clinical chemistry systems (ACE®, NExCT) to laboratories in the clinical diagnostic and veterinary marketplace as well as in the life scienc more...
www.alfawassermannus.com | Send Inquiry | Phone: +001-(800)-220-4488
FDA Registration: 2247288 Year Established: 1960 Annual Revenues: USD 10-25 Million Employee Count: ~160 Quality: ISO 9001, CE Certified
Products: Scrubs, Ferritin (FDA Code: DBF), Blood Analyzer Reagents, Calibrators for Equipment, Chemistry Analyzers, Glass & Plastic Bottles, ...
Alfa Wasserman Inc provides reliable & fully integrated clinical chemistry systems (ACE®, NExCT) to laboratories in the clinical diagnostic and veterinary marketplace as well as in the life scienc more...
Tas Medical Supply Inc | Address: 1256 55th Street, Brooklyn, New York 11219, USA
FDA Registration: 3007054491
Products: General Medical Supplies, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Glucose Glucose Dehydrogenase (FDA Code: LFR), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Tas Medical Supply Inc specializes in offering medical supplies. more...
FDA Registration: 3007054491
Products: General Medical Supplies, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Glucose Glucose Dehydrogenase (FDA Code: LFR), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Tas Medical Supply Inc specializes in offering medical supplies. more...
Biochemical Diagnostics, Inc. | Address: 180 Heartland Blvd., Edgewood, New York 11717-8314, USA
www.biochemicaldiagnostics.com | Send Inquiry | Phone: +1-(631)-595-9200, 800-223-4835
FDA Registration: 2432495 Year Established: 1981 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Reagents, Thin Layer Chromatography, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), P-Nitroaniline/Vanillin Vanilmandelic Acid Diazo Test (FDA Code: CDF), Drug Mixture Control Materials (FDA Code: DIF), Urine Screening Kit (FDA Code: JXA), ...
Biochemical Diagnostics, Inc. specializes in offering column hardware, liquid urine controls, thin layer chromatography, and microtiter configured sample preparation hardware. The Detectabuse controls more...
www.biochemicaldiagnostics.com | Send Inquiry | Phone: +1-(631)-595-9200, 800-223-4835
FDA Registration: 2432495 Year Established: 1981 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Reagents, Thin Layer Chromatography, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), P-Nitroaniline/Vanillin Vanilmandelic Acid Diazo Test (FDA Code: CDF), Drug Mixture Control Materials (FDA Code: DIF), Urine Screening Kit (FDA Code: JXA), ...
Biochemical Diagnostics, Inc. specializes in offering column hardware, liquid urine controls, thin layer chromatography, and microtiter configured sample preparation hardware. The Detectabuse controls more...
Chembio Diagnostic Systems, Inc. | Address: 3661 Horseblock Road, Medford, New York 11763, USA
www.chembio.com | Send Inquiry | Phone: +1-(631)-924-1135
FDA Registration: 2431980
Products: Chlamydia trachomatis IgA ELISA Kit, Chlamydia trachomatis IgG ELISA Kit, Chlamydia trachomatis IgM ELISA Kit, Chlamydia Trachomatis Real Time PCR Kit, Chlamydia Trachomatis IgG Kit, Chlamydia Trachomatis (FDA Code: MGM), ...
Chembio Diagnostic Systems, Inc. develops and manufactures point-of-care (POC) diagnostic tests and technology for infectious diseases. Our products serve diverse markets that are global. We also expo more...
www.chembio.com | Send Inquiry | Phone: +1-(631)-924-1135
FDA Registration: 2431980
Products: Chlamydia trachomatis IgA ELISA Kit, Chlamydia trachomatis IgG ELISA Kit, Chlamydia trachomatis IgM ELISA Kit, Chlamydia Trachomatis Real Time PCR Kit, Chlamydia Trachomatis IgG Kit, Chlamydia Trachomatis (FDA Code: MGM), ...
Chembio Diagnostic Systems, Inc. develops and manufactures point-of-care (POC) diagnostic tests and technology for infectious diseases. Our products serve diverse markets that are global. We also expo more...
Bayer Healthcare, LLC | Address: 555 White Plains Rd., 5th floor, Tarrytown, New York 10591, USA
www.bayerdiabetes.com | Phone: +1-(914)-366-1800
FDA Registration: 1826988
Products: Blood Glucose Meters, Blood Glucose Monitoring Systems, Blood Glucose Monitors, Diabetes Monitoring Products, Blood Glucose Monitor Kit, Diabetes Care Kit, ...
Bayer Healthcare, LLC focuses on diabetes care. We specialize in blood glucose meters. Our Breeze™ 2 blood glucose meter has features such as multi-test disc that eliminates individual strip han more...
www.bayerdiabetes.com | Phone: +1-(914)-366-1800
FDA Registration: 1826988
Products: Blood Glucose Meters, Blood Glucose Monitoring Systems, Blood Glucose Monitors, Diabetes Monitoring Products, Blood Glucose Monitor Kit, Diabetes Care Kit, ...
Bayer Healthcare, LLC focuses on diabetes care. We specialize in blood glucose meters. Our Breeze™ 2 blood glucose meter has features such as multi-test disc that eliminates individual strip han more...
Diagnostic Devices Inc. | Address: 9300 Harris Corners Parkway, Suite 450, Charlote, North Carolina 28269, USA
www.prodigymeter.com | Send Inquiry | Phone: +1-(704)-285-6400, 800-366-5901
Products: Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Diagnostic Devices Inc. offers diabetes products. We specialize in designing a meter that caters to the needs of the blind and low vision diabetic. We provide blood glucose monitoring systems. Our Pro more...
www.prodigymeter.com | Send Inquiry | Phone: +1-(704)-285-6400, 800-366-5901
Products: Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Diagnostic Devices Inc. offers diabetes products. We specialize in designing a meter that caters to the needs of the blind and low vision diabetic. We provide blood glucose monitoring systems. Our Pro more...
Prognostix, Inc. | Address: , Cleveland, Ohio 44106, USA
www.prognostix.com | Phone: +1-(216)-4457469
Products: Enzyme Immunoassay (EIA) Kits, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Primary Calibrator (FDA Code: JIS), Reagent Assembly Kits, Immunoassay Myeloperoxidase Test System (FDA Code: NTV), ...
Prognostix, Inc. develops and markets next-generation cardiovascular disease diagnostic products. Our CardioMPO™ test aids in the diagnosis of near-term heart attack and cardiac death risk. It i more...
www.prognostix.com | Phone: +1-(216)-4457469
Products: Enzyme Immunoassay (EIA) Kits, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Primary Calibrator (FDA Code: JIS), Reagent Assembly Kits, Immunoassay Myeloperoxidase Test System (FDA Code: NTV), ...
Prognostix, Inc. develops and markets next-generation cardiovascular disease diagnostic products. Our CardioMPO™ test aids in the diagnosis of near-term heart attack and cardiac death risk. It i more...
Fujirebio Diagnostics Inc | Address: 201 Great Valley Pkwy, Malvern, Pennsylvania 19355, USA
www.fdi.com | Send Inquiry | Phone: +1-(610)-240-3800
FDA Registration: 2521625 Year Established: 1998 Annual Revenues: USD 25-50 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Blood Bank Test Kits, Instruments, Immunoassays, Infectious Disease Identification Test Kits, Histology Test Kits, RIA Instruments, Multi Analyte Control (FDA Code: JJY), ...
Fujirebio Diagnostics Inc specializes in diagnostic products. Our product is used to detect the presence of cancer in the blood and sugar. more...
www.fdi.com | Send Inquiry | Phone: +1-(610)-240-3800
FDA Registration: 2521625 Year Established: 1998 Annual Revenues: USD 25-50 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Blood Bank Test Kits, Instruments, Immunoassays, Infectious Disease Identification Test Kits, Histology Test Kits, RIA Instruments, Multi Analyte Control (FDA Code: JJY), ...
Fujirebio Diagnostics Inc specializes in diagnostic products. Our product is used to detect the presence of cancer in the blood and sugar. more...
Dalton Instrument Corporation | Address: 3788 Arapaho Road, Addison, Texas 75001, USA
www.daltoninstrument.com | Send Inquiry | Phone: +1-(469)-522-1200
Products: Oxygen Masks (FDA Code: BYG), Patient Lifters (FDA Code: FNG), Clamps, Forceps (FDA Code: HTD), Urinary Leg Bags, Nebulizers, ...
Dalton Instrument Corporation specializes in providing products to the medical care industry. Our product line includes categories in durable medical equipments & disposable medical devices such as ho more...
www.daltoninstrument.com | Send Inquiry | Phone: +1-(469)-522-1200
Products: Oxygen Masks (FDA Code: BYG), Patient Lifters (FDA Code: FNG), Clamps, Forceps (FDA Code: HTD), Urinary Leg Bags, Nebulizers, ...
Dalton Instrument Corporation specializes in providing products to the medical care industry. Our product line includes categories in durable medical equipments & disposable medical devices such as ho more...
Applied Diabetes Research, Inc. | Address: 1420 Valwood Parkway, Suite 205, Carrollton, Texas 75006, USA
www.applieddiabetesresearch.org | Send Inquiry | Phone: +1-(972)-241-1884
Products: Safety Syringes, Syringe Reservoirs, Insulin Infusion Sets, Cannulas, Infusion Systems, Syringes, ...
Applied Diabetes Research, Inc. is engaged in the production of diabetic products. Our product line comprises of insulin infusion sets, Medtronic Minimed Paradigm® pump and Medtronic Minimed 500 s more...
www.applieddiabetesresearch.org | Send Inquiry | Phone: +1-(972)-241-1884
Products: Safety Syringes, Syringe Reservoirs, Insulin Infusion Sets, Cannulas, Infusion Systems, Syringes, ...
Applied Diabetes Research, Inc. is engaged in the production of diabetic products. Our product line comprises of insulin infusion sets, Medtronic Minimed Paradigm® pump and Medtronic Minimed 500 s more...
Maxwell Medical Services Inc | Address: 355 E Ramsey Road, San Antonio, Texas 78216, USA
Products: General Medical Supplies, Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Maxwell Medical Services Inc specializes in offering medical supplies. more...
Products: General Medical Supplies, Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Maxwell Medical Services Inc specializes in offering medical supplies. more...
Third Wave Technologies, Inc. | Address: 502 South Rosa Rd., Madison, Wisconsin 53719-1256, USA
www.twt.com | Phone: +1-(608)-273-8933, 888-898-2357
Year Established: 1993 Employee Count: ~180
Products: Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Reagents, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Cystic Fibrosis Test, General Purpose Reagent (FDA Code: LDT), ...
Third Wave Technologies, Inc. offers invader chemistry and IVD products for clinical customers. The Invader® chemistry provides molecular solutions to any lab, and is composed of two simultaneous more...
www.twt.com | Phone: +1-(608)-273-8933, 888-898-2357
Year Established: 1993 Employee Count: ~180
Products: Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Reagents, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Cystic Fibrosis Test, General Purpose Reagent (FDA Code: LDT), ...
Third Wave Technologies, Inc. offers invader chemistry and IVD products for clinical customers. The Invader® chemistry provides molecular solutions to any lab, and is composed of two simultaneous more...
RR Donnelley-Global Turnkey Solutions | Address: 1600 Disk Dr., Plover, Wisconsin 54467, USA
Phone: +1-(757)-2240177
FDA Registration: 3006371704
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Glucose Glucose Dehydrogenase (FDA Code: LFR), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Therapeutic Intravascular Catheter (FDA Code: LJS), ...
RR Donnelley-Global Turnkey Solutions specializes in glucose dehydrogenase, incontinence protective garment, therapeutic intravascular catheters, and unscented menstrual tampons. more...
Phone: +1-(757)-2240177
FDA Registration: 3006371704
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Oxidase, Glucose (FDA Code: CGA), Glucose Glucose Dehydrogenase (FDA Code: LFR), Urinary Ketones, Nitroprusside Test (FDA Code: JIN), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Therapeutic Intravascular Catheter (FDA Code: LJS), ...
RR Donnelley-Global Turnkey Solutions specializes in glucose dehydrogenase, incontinence protective garment, therapeutic intravascular catheters, and unscented menstrual tampons. more...
The Binding Site Group Limited | Address: PO Box 11712, Birmingham B14 4ZB, United Kingdom 
www.bindingsite.com | Send Inquiry | Phone: +44-(121)-436-1000
FDA Registration: 9614373 Year Established: 1983
Products: Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Nephelometer (FDA Code: JZW), Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Pipetting and Diluting Station (FDA Code: JQW), Secondary Calibrator (FDA Code: JIT), ...
The Binding Site Group Limited specializes in the research, development and manufacture of immunodiagnostic assays in the fields of multiple myeloma & investigation of the immune response. Hevylite&tr more...
www.bindingsite.com | Send Inquiry | Phone: +44-(121)-436-1000
FDA Registration: 9614373 Year Established: 1983
Products: Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Nephelometer (FDA Code: JZW), Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Pipetting and Diluting Station (FDA Code: JQW), Secondary Calibrator (FDA Code: JIT), ...
The Binding Site Group Limited specializes in the research, development and manufacture of immunodiagnostic assays in the fields of multiple myeloma & investigation of the immune response. Hevylite&tr more...
Axis-Shield Diagnostics, Ltd. | Address: The Technology Park, Dundee, Scotland DD2 1XA, United Kingdom
www.axis-shield.com | Phone: +44-(1382)-422000
FDA Registration: 8032314
Products: Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Multi Analyte Mixture - Calibrator (FDA Code: JIX), Primary Calibrator (FDA Code: JIS), Secondary Calibrator (FDA Code: JIT), Testosterones and Dihydrotestosterone Radioimmunoassay (FDA Code: CDZ), ...
Axis-Shield Diagnostics, Ltd. focuses on the development and manufacture of in vitro diagnostic tests for use in clinical laboratories and at the point of care. We specialize in the supply of point of more...
www.axis-shield.com | Phone: +44-(1382)-422000
FDA Registration: 8032314
Products: Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Multi Analyte Mixture - Calibrator (FDA Code: JIX), Primary Calibrator (FDA Code: JIS), Secondary Calibrator (FDA Code: JIT), Testosterones and Dihydrotestosterone Radioimmunoassay (FDA Code: CDZ), ...
Axis-Shield Diagnostics, Ltd. focuses on the development and manufacture of in vitro diagnostic tests for use in clinical laboratories and at the point of care. We specialize in the supply of point of more...
E.G.& G. Ltd. | Address: 20 Vincent Ave., Milton Keynes MK8 OAB, United Kingdom
Phone: +44-(1908)-265-744
Employee Count: ~30 Quality: ISO 9002, CE Certified
Products: Neonatal Monitors, Neonatal Monitoring Electrodes, Programmable Diagnostic Computer (FDA Code: DQK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), Liquid Scintillation Counting Vial, ...
E.G.& G. Ltd. specializes in offering products for the life science and medical industries. Our Wallac Microbeta Trilux liquid scintillation and luminescence counter is a versatile instrument optimize more...
Phone: +44-(1908)-265-744
Employee Count: ~30 Quality: ISO 9002, CE Certified
Products: Neonatal Monitors, Neonatal Monitoring Electrodes, Programmable Diagnostic Computer (FDA Code: DQK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), Liquid Scintillation Counting Vial, ...
E.G.& G. Ltd. specializes in offering products for the life science and medical industries. Our Wallac Microbeta Trilux liquid scintillation and luminescence counter is a versatile instrument optimize more...
Horiba | Address: Warren Court, shefford SG17 5QB, United Kingdom
www.horiba-abx.com/uk | Send Inquiry | Phone: +44-(1462)-814400
FDA Registration: 1000256526 Year Established: 1983 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO Certified
Products: Hematology Analyzers, Myoglobin (FDA Code: DDR), Blood, Hematology Analyzers, Automated Hematology Analyzers, Refurbished Hematology Analyzers, Smaller Hematology Analyzers, ...
Horiba designs and manufactures systems for analyzing & measuring liquids, gases and solids. Our ABX pentra 400 is an extremely compact clinical chemistry benchtop analyser, which is autonomy with con more...
www.horiba-abx.com/uk | Send Inquiry | Phone: +44-(1462)-814400
FDA Registration: 1000256526 Year Established: 1983 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO Certified
Products: Hematology Analyzers, Myoglobin (FDA Code: DDR), Blood, Hematology Analyzers, Automated Hematology Analyzers, Refurbished Hematology Analyzers, Smaller Hematology Analyzers, ...
Horiba designs and manufactures systems for analyzing & measuring liquids, gases and solids. Our ABX pentra 400 is an extremely compact clinical chemistry benchtop analyser, which is autonomy with con more...
Cambridge Sensors Limited | Address: Units 9&10 Cardinal Park, Godmanchester, Huntingdon, Cambridgeshire PE29 2XG, United Kingdom
www.cs-limited.co.uk | Send Inquiry | Phone: +44-(1480)-482920
FDA Registration: 3004176168 Quality: ISO9001: 2000, ISO:13485, EN46001 Certified
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Glucose Dehydrogenase (FDA Code: LFR), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Cambridge Sensors Limited designs and manufactures blood glucose test strips for use in blood glucose test systems. We have developed customisable blood glucose test strip that can be used with custom more...
www.cs-limited.co.uk | Send Inquiry | Phone: +44-(1480)-482920
FDA Registration: 3004176168 Quality: ISO9001: 2000, ISO:13485, EN46001 Certified
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Glucose Glucose Dehydrogenase (FDA Code: LFR), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Cambridge Sensors Limited designs and manufactures blood glucose test strips for use in blood glucose test systems. We have developed customisable blood glucose test strip that can be used with custom more...
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FDA Code / Regulation: 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.
Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.
