Multi Analyte Control Suppliers
Limit companies to: Worldwide USA
Abbott Hematology | Address: 5440 Patrick Henry Dr., Santa Clara, California 95054, USA 
www.abbott.us | Phone: +1-(408)-982-4800
FDA Registration: 2919069 Employee Count: ~72000 Quality: ISO 9001, CE Certified
Products: Myoglobin (FDA Code: DDR), Catheter Introducers (FDA Code: DYB), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Carotid Stent Systems (FDA Code: NIM), Diagnostic Instruments, ...
Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a more...
www.abbott.us | Phone: +1-(408)-982-4800
FDA Registration: 2919069 Employee Count: ~72000 Quality: ISO 9001, CE Certified
Products: Myoglobin (FDA Code: DDR), Catheter Introducers (FDA Code: DYB), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Carotid Stent Systems (FDA Code: NIM), Diagnostic Instruments, ...
Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a more...
Utak Laboratories, Inc. | Address: 25020 Ave Tibbitts, Valencia, California 91355, USA
www.utak.com | Send Inquiry | Phone: +1-(661)-294-3935, 800-235-3442
FDA Registration: 2022375 Annual Revenues: < USD 1 Million
Products: Fluid Control Solidifier, Urine Dipstick Control, Multi Analyte Control (FDA Code: JJY), Drug Mixture Control Materials (FDA Code: DIF), Drug Specific Control Test (FDA Code: LAS), Drugs of Abuse Test Systems (FDA Code: MGX), ...
Utak Laboratories, Inc. deals with adulteration controls, oral fluid controls, serum controls, urine controls and whole blood controls. Our whole blood drugs of abuse contain benzoylecgonine, cocaine, more...
www.utak.com | Send Inquiry | Phone: +1-(661)-294-3935, 800-235-3442
FDA Registration: 2022375 Annual Revenues: < USD 1 Million
Products: Fluid Control Solidifier, Urine Dipstick Control, Multi Analyte Control (FDA Code: JJY), Drug Mixture Control Materials (FDA Code: DIF), Drug Specific Control Test (FDA Code: LAS), Drugs of Abuse Test Systems (FDA Code: MGX), ...
Utak Laboratories, Inc. deals with adulteration controls, oral fluid controls, serum controls, urine controls and whole blood controls. Our whole blood drugs of abuse contain benzoylecgonine, cocaine, more...
International Bioanalytical Reagents | Address: 3495 North Dixie Highway, Unit 8, Boca Raton, Florida 33431, USA
ibireagents.com | Send Inquiry | Phone: +1-(954)-324-5106
Products: Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), Multi Analyte Control (FDA Code: JJY), Amylase Catalytic Method Test (FDA Code: JFJ), Amylase Nephelometric (FDA Code: KHM), Amylase Saccharogenic Test (FDA Code: CIJ), ...
International Bioanalytical Reagents is a distributor of diagnostic test kits and services. more...
ibireagents.com | Send Inquiry | Phone: +1-(954)-324-5106
Products: Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), Multi Analyte Control (FDA Code: JJY), Amylase Catalytic Method Test (FDA Code: JFJ), Amylase Nephelometric (FDA Code: KHM), Amylase Saccharogenic Test (FDA Code: CIJ), ...
International Bioanalytical Reagents is a distributor of diagnostic test kits and services. more...
JAS Diagnostics, Inc | Address: 7220 NW 58th Street, Miami, Florida 33166, USA
www.jasdiagnostics.com | Send Inquiry | Phone: +1-(305)-418-2320
FDA Registration: 1064608 Annual Revenues: USD 1-5 Million
Products: Blood Analyzer Reagents, Calibrators for Equipment, Controls for Diagnostic Equipment, General Diagnostic Supplies, Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB), ...
JAS Diagnostics, Inc supplies laboratories with valued diagnostics products. Many of our diagnostic chemistry reagents supply the laboratory with the convenience & stability of state-of-the-art, singl more...
www.jasdiagnostics.com | Send Inquiry | Phone: +1-(305)-418-2320
FDA Registration: 1064608 Annual Revenues: USD 1-5 Million
Products: Blood Analyzer Reagents, Calibrators for Equipment, Controls for Diagnostic Equipment, General Diagnostic Supplies, Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB), ...
JAS Diagnostics, Inc supplies laboratories with valued diagnostics products. Many of our diagnostic chemistry reagents supply the laboratory with the convenience & stability of state-of-the-art, singl more...
Bioresource Technology, Inc. | Address: 11924 Miramar Parkway, Miramar, Florida 33025, USA
www.bioresourcetech.com | Send Inquiry | Phone: +1-(800)-553 5975
FDA Registration: 1058931
Products: Fertility Products, Human Serum Albumin, Multi Analyte Control (FDA Code: JJY), Normal And Abnormal Hemoglobin Standards And Controls (FDA Code: GFS), ...
Bioresource Technology, Inc. is a supplier of process serum bases to the bio diagnostic control industry. The product line includes custom diagnostic base pools for control matrixes, antibody screened more...
www.bioresourcetech.com | Send Inquiry | Phone: +1-(800)-553 5975
FDA Registration: 1058931
Products: Fertility Products, Human Serum Albumin, Multi Analyte Control (FDA Code: JJY), Normal And Abnormal Hemoglobin Standards And Controls (FDA Code: GFS), ...
Bioresource Technology, Inc. is a supplier of process serum bases to the bio diagnostic control industry. The product line includes custom diagnostic base pools for control matrixes, antibody screened more...
Health Chem Diagnostics LLC | Address: 3341 S.W. 15th St., Pompano Beach, Florida 33069-4808, USA
www.healthchemdiagnostics.com | Send Inquiry | Phone: +1-(954)-979-3845
FDA Registration: 1048532
Products: Fertility Monitors, Pregnancy Test Kits, Cholesterol Testing and Cholesterol Monitoring Kits, Infectious Disease Test Kits, Cardiac Markers, Alpha-Fetoprotein Rapid Test Strip, Fecal Occult Blood Test Strip, ...
Health Chem Diagnostics LLC manufactures point-of-care medical diagnostic products for use at home, in physician office, and in other healthcare locations & markets. Our products are alcohol testing, more...
www.healthchemdiagnostics.com | Send Inquiry | Phone: +1-(954)-979-3845
FDA Registration: 1048532
Products: Fertility Monitors, Pregnancy Test Kits, Cholesterol Testing and Cholesterol Monitoring Kits, Infectious Disease Test Kits, Cardiac Markers, Alpha-Fetoprotein Rapid Test Strip, Fecal Occult Blood Test Strip, ...
Health Chem Diagnostics LLC manufactures point-of-care medical diagnostic products for use at home, in physician office, and in other healthcare locations & markets. Our products are alcohol testing, more...
Sebia Electrophoresis | Address: 400-1705 Corporate Dr, Norcross, Georgia 30093, USA
www.sebia-usa.com | Phone: +1-(770)-446-3707
Year Established: 1997 Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Publications, Scanners, Publications Service, Electrophoresis Calibrators & Controls, Electrophoresis Reagents & Test Kits, Electrophoresis Instruments, ...
Sebia Electrophoresis focuses on clinical electrophoresis laboratories. We supply capillary electrophoresis systems, Hydrasys®, Hydraplus™ and scanners & densitometers. Our Hydrasys® is more...
www.sebia-usa.com | Phone: +1-(770)-446-3707
Year Established: 1997 Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Publications, Scanners, Publications Service, Electrophoresis Calibrators & Controls, Electrophoresis Reagents & Test Kits, Electrophoresis Instruments, ...
Sebia Electrophoresis focuses on clinical electrophoresis laboratories. We supply capillary electrophoresis systems, Hydrasys®, Hydraplus™ and scanners & densitometers. Our Hydrasys® is more...
OPTI Medical, Inc. | Address: 235 Hembree Park Drive, Roswell, Georgia 30076, USA
www.optimedical.com | Phone: +1-(770)-510-4444, 800-490-6784
FDA Registration: 3004102403
Products: Blood Gas Analyzers, Oximeters (FDA Code: DQA), Blood Gas & Electrolyte Analyzers, Portable Oxygen Concentrator Analyzer w/ Sensor, Dry and Liquid Heparin Arterial Blood Sampling Kits, Arterial Blood Sampling Kit (FDA Code: CBT), ...
OPTI Medical, Inc. focuses on portable instruments for measurement of time sensitive diagnostics tests such as blood gas, electrolyte and metabolite analysis. These analyzers are primarily used in the more...
www.optimedical.com | Phone: +1-(770)-510-4444, 800-490-6784
FDA Registration: 3004102403
Products: Blood Gas Analyzers, Oximeters (FDA Code: DQA), Blood Gas & Electrolyte Analyzers, Portable Oxygen Concentrator Analyzer w/ Sensor, Dry and Liquid Heparin Arterial Blood Sampling Kits, Arterial Blood Sampling Kit (FDA Code: CBT), ...
OPTI Medical, Inc. focuses on portable instruments for measurement of time sensitive diagnostics tests such as blood gas, electrolyte and metabolite analysis. These analyzers are primarily used in the more...
Analytical Control Systems, Inc. | Address: 9058 Technology Drive, Fishers, Indiana 46038, USA
www.analyticalcontrols.com | Send Inquiry | Phone: +1-(317)-841-0458
FDA Registration: 1825740 Year Established: 1978 Annual Revenues: USD 1-5 Million
Products: Reagents, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Abnormal Plasma Control (FDA Code: GGC), Activated Partial Thromboplastin (FDA Code: GFO), Activated Whole Blood Clotting Time (FDA Code: JBP), ...
Analytical Control Systems, Inc. is a manufacturer of diagnostic controls, reagents and test products. We offer newborn screening products such as gal-1-put, hemoglobin variant controls such as AF, AS more...
www.analyticalcontrols.com | Send Inquiry | Phone: +1-(317)-841-0458
FDA Registration: 1825740 Year Established: 1978 Annual Revenues: USD 1-5 Million
Products: Reagents, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Abnormal Plasma Control (FDA Code: GGC), Activated Partial Thromboplastin (FDA Code: GFO), Activated Whole Blood Clotting Time (FDA Code: JBP), ...
Analytical Control Systems, Inc. is a manufacturer of diagnostic controls, reagents and test products. We offer newborn screening products such as gal-1-put, hemoglobin variant controls such as AF, AS more...
Creative Laboratory Products, Inc. | Address: 6420 N. Guion Rd., Indianapolis, Indiana 46268, USA
www.clplipids.com | Send Inquiry | Phone: +1-(317)-293-2991
FDA Registration: 1832818 Year Established: 1987 Annual Revenues: < USD 1 Million
Products: Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), HDL Precipitation Method (FDA Code: LBR), LDL & VLDL Precipitation Method (FDA Code: LBR), Electrophoretic, Lactate Dehydrogenase Isoenzymes (FDA Code: CFE), Lipid Standard, ...
Creative Laboratory Products, Inc. specializes in manufacturing lipid additives. Our products are widely used by the manufacturers of liquid and lyophilized lipid controls. We produce lipid quality co more...
www.clplipids.com | Send Inquiry | Phone: +1-(317)-293-2991
FDA Registration: 1832818 Year Established: 1987 Annual Revenues: < USD 1 Million
Products: Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), HDL Precipitation Method (FDA Code: LBR), LDL & VLDL Precipitation Method (FDA Code: LBR), Electrophoretic, Lactate Dehydrogenase Isoenzymes (FDA Code: CFE), Lipid Standard, ...
Creative Laboratory Products, Inc. specializes in manufacturing lipid additives. Our products are widely used by the manufacturers of liquid and lyophilized lipid controls. We produce lipid quality co more...
Roche Diagnostics | Address: 9115 Hague Road, P.O. Box 50457, Indianapolis, Indiana 46250, USA
www.roche-diagnostics.us | Phone: +1-(317)-521-2000
Annual Revenues: USD 100-500 Million Employee Count: ~140 Quality: ISO 9000, CE Certified
Products: Blood Glucose Meters, Immunoassay Systems, Immunochemistry Analyzers, Myoglobin (FDA Code: DDR), Lancet Devices, Diagnostic Systems, Lancet, ...
Roche Diagnostics offers diagnostic tests and systems in the area of integrated healthcare solutions. Our products cover the early detection, targeted screening, evaluation and monitoring of the disea more...
www.roche-diagnostics.us | Phone: +1-(317)-521-2000
Annual Revenues: USD 100-500 Million Employee Count: ~140 Quality: ISO 9000, CE Certified
Products: Blood Glucose Meters, Immunoassay Systems, Immunochemistry Analyzers, Myoglobin (FDA Code: DDR), Lancet Devices, Diagnostic Systems, Lancet, ...
Roche Diagnostics offers diagnostic tests and systems in the area of integrated healthcare solutions. Our products cover the early detection, targeted screening, evaluation and monitoring of the disea more...
Bioprocessing, Inc. | Address: 1045 Riverside St, Portland, Maine 04103, USA
www.bioprocessinginc.com | Send Inquiry | Phone: +1-(207)-457-0025
Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Tumor Markers, Multi Analyte Control (FDA Code: JJY), Custom Control Serums, Tumor Cell Line Pallets, ...
Bioprocessing, Inc. is a manufacturer of specialized raw materials for use in the diagnostic industry. Our product line includes novel tumor marker antigens, tumor sell line pellets, custom control se more...
www.bioprocessinginc.com | Send Inquiry | Phone: +1-(207)-457-0025
Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Tumor Markers, Multi Analyte Control (FDA Code: JJY), Custom Control Serums, Tumor Cell Line Pallets, ...
Bioprocessing, Inc. is a manufacturer of specialized raw materials for use in the diagnostic industry. Our product line includes novel tumor marker antigens, tumor sell line pellets, custom control se more...
Maine Standards Company, LLC | Address: 765 Roosevelt Trail, Suite 9A, Windham, Maine 04062-5365, USA
www.mainestandards.com | Send Inquiry | Phone: +1-(207)-892-1300, 800-377-9684
FDA Registration: 1226774 Year Established: 2001 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO Certified
Products: Enzymes, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Multi Analyte Mixture - Calibrator (FDA Code: JIX), Drug Mixture Calibrator (FDA Code: DKB), ...
Maine Standards Company, LLC specializes in calibration verification and linearity. Our Validate® test kits are linearity test sets designed for calibration verification, reportable range validati more...
www.mainestandards.com | Send Inquiry | Phone: +1-(207)-892-1300, 800-377-9684
FDA Registration: 1226774 Year Established: 2001 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO Certified
Products: Enzymes, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Multi Analyte Mixture - Calibrator (FDA Code: JIX), Drug Mixture Calibrator (FDA Code: DKB), ...
Maine Standards Company, LLC specializes in calibration verification and linearity. Our Validate® test kits are linearity test sets designed for calibration verification, reportable range validati more...
BBI Diagnostics | Address: 375 West St, West Bridgewater, Maryland 02379, USA
www.bbii.com | Phone: +1-(508)-580-1900
FDA Registration: 2022994 Annual Revenues: USD 5-10 Million Quality: ISO 9001, CE Certified
Products: Controls, Controls for Diagnostic Equipment, Blood Bank Test Kits, Immunoassays, Infectious Disease Test Kits, Multi Analyte Control (FDA Code: JJY), ...
BBI Diagnostics manufactures biological based materials. Our products are used in diagnostic tests, commercial bioproduction of therapeutic drugs and additional research applications. We focus on biot more...
www.bbii.com | Phone: +1-(508)-580-1900
FDA Registration: 2022994 Annual Revenues: USD 5-10 Million Quality: ISO 9001, CE Certified
Products: Controls, Controls for Diagnostic Equipment, Blood Bank Test Kits, Immunoassays, Infectious Disease Test Kits, Multi Analyte Control (FDA Code: JJY), ...
BBI Diagnostics manufactures biological based materials. Our products are used in diagnostic tests, commercial bioproduction of therapeutic drugs and additional research applications. We focus on biot more...
Medica Corporation | Address: 5 Oak Park Drive, Bedford, Massachusetts 01730, USA
www.medicacorp.com | Send Inquiry | Phone: +1-(800)-777-5983
FDA Registration: 1220972 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: CE Certified
Products: Infect Waste & Linen Disposal, Ulcer, Burn & Wound Dressings, Blood Gas/pH analyzer, Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), Multi Analyte Control (FDA Code: JJY), Amylase Catalytic Method Test (FDA Code: JFJ), ...
Medica Corporation supplies blood testing analysers. These analysers are of low cost, easy to use & are easy to maintain. We have introduced EasyRA, a fully automated, random access clinical chemistry more...
www.medicacorp.com | Send Inquiry | Phone: +1-(800)-777-5983
FDA Registration: 1220972 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: CE Certified
Products: Infect Waste & Linen Disposal, Ulcer, Burn & Wound Dressings, Blood Gas/pH analyzer, Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), Multi Analyte Control (FDA Code: JJY), Amylase Catalytic Method Test (FDA Code: JFJ), ...
Medica Corporation supplies blood testing analysers. These analysers are of low cost, easy to use & are easy to maintain. We have introduced EasyRA, a fully automated, random access clinical chemistry more...
Bionostics Inc. | Address: 7 Jackson Rd., Devens, Massachusetts 01434, USA
www.bionostics.com | Send Inquiry | Phone: +1-(978)-772-7070
FDA Registration: 1220649 Year Established: 1981
Products: Capillary Blood Collection Tubes (FDA Code: GIO), pH Buffer (FDA Code: JCC), pH Buffer Calibration Solutions, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Blood Collection Systems (FDA Code: JKA), ...
Bionostics Inc. provides medical device manufacturers with services for the development, manufacturing and packaging of calibration & quality control liquids. more...
www.bionostics.com | Send Inquiry | Phone: +1-(978)-772-7070
FDA Registration: 1220649 Year Established: 1981
Products: Capillary Blood Collection Tubes (FDA Code: GIO), pH Buffer (FDA Code: JCC), pH Buffer Calibration Solutions, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Blood Collection Systems (FDA Code: JKA), ...
Bionostics Inc. provides medical device manufacturers with services for the development, manufacturing and packaging of calibration & quality control liquids. more...
SeraCare Life Sciences, Inc. | Address: 37 Birch Street, Milford, Massachusetts 01757, USA
www.seracare.com | Send Inquiry | Phone: +1-(508)-244-6400
FDA Registration: 3007088335 Year Established: 1984 Annual Revenues: USD 25-50 Million Employee Count: ~50 Quality: ISO Certified
Products: Swabs, Laboratory Information Systems, Centrifuges, Preps & Swabs, Cotton Swabs, Swabs, Absorbing, ...
SeraCare Life Sciences, Inc. manufactures and sells biological based materials. We focus on biotechnology, pharmaceutical and diagnostic industries. We are certified with ISO 13485 standard. Our produ more...
www.seracare.com | Send Inquiry | Phone: +1-(508)-244-6400
FDA Registration: 3007088335 Year Established: 1984 Annual Revenues: USD 25-50 Million Employee Count: ~50 Quality: ISO Certified
Products: Swabs, Laboratory Information Systems, Centrifuges, Preps & Swabs, Cotton Swabs, Swabs, Absorbing, ...
SeraCare Life Sciences, Inc. manufactures and sells biological based materials. We focus on biotechnology, pharmaceutical and diagnostic industries. We are certified with ISO 13485 standard. Our produ more...
Phoenix Diagnostics, Inc. | Address: 8 Tech Circle, Natick, Massachusetts 01760, USA
www.phoenixdiagnostics.com | Phone: +1-(508)-655-8310, 800-688-2595
FDA Registration: 1222035 Year Established: 1989 Annual Revenues: < USD 1 Million
Products: Multi Analyte Control (FDA Code: JJY), Blood Gas Controls (FDA Code: JJS), Blood Gas and Ph Electrode Measurement (FDA Code: CHL), Multi Analyte Mixture - Calibrator (FDA Code: JIX), Chloride Ion Specific Electrode (FDA Code: CGZ), Electrolyte Control (FDA Code: JJR), ...
Phoenix Diagnostics, Inc. is a manufacturer of consumables for blood gas, electrolyte, co-oximetry, and chemistry analyzers. We focus on the private-label manufacturing of quality controls and calibra more...
www.phoenixdiagnostics.com | Phone: +1-(508)-655-8310, 800-688-2595
FDA Registration: 1222035 Year Established: 1989 Annual Revenues: < USD 1 Million
Products: Multi Analyte Control (FDA Code: JJY), Blood Gas Controls (FDA Code: JJS), Blood Gas and Ph Electrode Measurement (FDA Code: CHL), Multi Analyte Mixture - Calibrator (FDA Code: JIX), Chloride Ion Specific Electrode (FDA Code: CGZ), Electrolyte Control (FDA Code: JJR), ...
Phoenix Diagnostics, Inc. is a manufacturer of consumables for blood gas, electrolyte, co-oximetry, and chemistry analyzers. We focus on the private-label manufacturing of quality controls and calibra more...
Axis-Shield USA | Address: 10 Commerce Way, Norton, Massachusetts 02766, USA
www.axis-shield-poc.com | Send Inquiry | Phone: +1-(508)-2854870
Year Established: 2005
Products: Calibrators, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Creatinine Enzymatic Method Test (FDA Code: JFY), Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Reflectance Densitometer/Scanner (FDA Code: JQT), ...
Axis-Shield USA is a healthcare company comprising a laboratory and a point of care business backed by a R&D division. We develop, manufacture, & market sales of in-vitro diagnostic products. Our seve more...
www.axis-shield-poc.com | Send Inquiry | Phone: +1-(508)-2854870
Year Established: 2005
Products: Calibrators, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Creatinine Enzymatic Method Test (FDA Code: JFY), Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Reflectance Densitometer/Scanner (FDA Code: JQT), ...
Axis-Shield USA is a healthcare company comprising a laboratory and a point of care business backed by a R&D division. We develop, manufacture, & market sales of in-vitro diagnostic products. Our seve more...
Verax Biomedical Incorporated | Address: 377 Plantation Street, 4 Biotech, Worcester, Massachusetts 01605, USA
www.veraxbiomedical.com | Send Inquiry | Phone: +1-(508)-7557029, 866 948 3729
FDA Registration: 3005935106
Products: Multi Analyte Control (FDA Code: JJY), Bacterial Detection System For Platelet Transfusion Products (FDA Code: MZC), Platelet Pan Genera Detection (pgd) Tests, Cell Therapy Pan Genera Detection (pgd) Tests, Red Cell Pan Genera Detection (pgd) Tests, ...
Verax Biomedical Inc.develops rapid tests. These tests help in the detection of bacterial contaminants in blood components, tissues for transplantation and cellular therapies. Our tests are based upon more...
www.veraxbiomedical.com | Send Inquiry | Phone: +1-(508)-7557029, 866 948 3729
FDA Registration: 3005935106
Products: Multi Analyte Control (FDA Code: JJY), Bacterial Detection System For Platelet Transfusion Products (FDA Code: MZC), Platelet Pan Genera Detection (pgd) Tests, Cell Therapy Pan Genera Detection (pgd) Tests, Red Cell Pan Genera Detection (pgd) Tests, ...
Verax Biomedical Inc.develops rapid tests. These tests help in the detection of bacterial contaminants in blood components, tissues for transplantation and cellular therapies. Our tests are based upon more...
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FDA Code / Regulation: JJY / 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.
