Assayed and Unassayed Single (Specified) Analyte Controls Suppliers
Limit companies to: Worldwide USA
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, Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), ...
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, Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), ...
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...
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, Alpha-Fetoprotein Rapid Test Strip, Fecal Occult Blood Test Strip, BreathScanr Alcohol Detector, Prostate Specific Antigen Test (FDA Code: MTG), Urine Teststrips, ...
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, Alpha-Fetoprotein Rapid Test Strip, Fecal Occult Blood Test Strip, BreathScanr Alcohol Detector, Prostate Specific Antigen Test (FDA Code: MTG), Urine Teststrips, ...
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, Publications Service, Electrophoresis Calibrators & Controls, Electrophoresis Reagents & Test Kits, Electrophoresis Instruments, Hemoglobin S (FDA Code: GIQ), ...
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, Publications Service, Electrophoresis Calibrators & Controls, Electrophoresis Reagents & Test Kits, Electrophoresis Instruments, Hemoglobin S (FDA Code: GIQ), ...
Sebia Electrophoresis focuses on clinical electrophoresis laboratories. We supply capillary electrophoresis systems, Hydrasys®, Hydraplus™ and scanners & densitometers. Our Hydrasys® is 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: 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), Alkali Resistant Hemoglobin (FDA Code: GHA), Control Thromboplastin Reagent (FDA Code: GGO), ...
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: 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), Alkali Resistant Hemoglobin (FDA Code: GHA), Control Thromboplastin Reagent (FDA Code: GGO), ...
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: 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), Control Antiserum Antigen Cholinesterase, Abnormal Hemoglobin Control (FDA Code: JCM), ...
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: 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), Control Antiserum Antigen Cholinesterase, Abnormal Hemoglobin Control (FDA Code: JCM), ...
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, Diagnostic Systems, Lancet, clinical Chemistry and Immunochemistry Analyzer, Diagnostic Products, Blood Coagulation Systems, Capillary Tube Accessories, ...
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, Diagnostic Systems, Lancet, clinical Chemistry and Immunochemistry Analyzer, Diagnostic Products, Blood Coagulation Systems, Capillary Tube Accessories, ...
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...
Eurotrol Inc. | Address: 850 N. Black Branch Rd, Elizabethtown, Kentucky 42701, USA
https://www.eurotrol.com/en | Send Inquiry | Phone: +1-(502)-501-1180
Year Established: 1988 Employee Count: ~60
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Blood Gas Controls (FDA Code: JJS), Hemoglobin Control (FDA Code: GGM), ...
Eurotrol Inc. provides high-specification, custom-made materials for the periodic verification of in-vitro diagnostic analyzers. We have developed different products covering a wide range of tests, in more...
https://www.eurotrol.com/en | Send Inquiry | Phone: +1-(502)-501-1180
Year Established: 1988 Employee Count: ~60
Products: Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Blood Gas Controls (FDA Code: JJS), Hemoglobin Control (FDA Code: GGM), ...
Eurotrol Inc. provides high-specification, custom-made materials for the periodic verification of in-vitro diagnostic analyzers. We have developed different products covering a wide range of tests, in 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...
Genzyme Diagnostics | Address: One Kendall Square, Cambridge, Massachusetts 02139-1562, USA
www.genzymediagnostics.com | Send Inquiry | Phone: +1-(508)-661-1835
FDA Registration: 2030538
Products: Infectious Disease Exams, Microbiology Kit, General Diagnostic Supplies, General Medical Supplies, Pregnancy Kits, Water-microbiology kit, ...
Genzyme Diagnostics offers a unique product portfolio for diagnostic manufacturers and clinical laboratories. Our product OSOM® Mono is ideal for the qualitative detection of infectious mononucleo more...
www.genzymediagnostics.com | Send Inquiry | Phone: +1-(508)-661-1835
FDA Registration: 2030538
Products: Infectious Disease Exams, Microbiology Kit, General Diagnostic Supplies, General Medical Supplies, Pregnancy Kits, Water-microbiology kit, ...
Genzyme Diagnostics offers a unique product portfolio for diagnostic manufacturers and clinical laboratories. Our product OSOM® Mono is ideal for the qualitative detection of infectious mononucleo more...
Amnisure International, LLC | Address: 30 Jfk Street 4th Floor, Cambridge, Massachusetts 02138, USA
www.amnisure.com | Send Inquiry | Phone: +1-(617)-2344441
Quality: ISO13485:2003 Certified
Products: Non-invasive H Pylori Testing Kit, Track Etched Membranes, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Placental Alpha-1 Microglobulin (Pamg-1) Immunoassay (FDA Code: NQM), Barrier Membranes, ...
Amnisure International, LLC manufactures rapid and non-invasive test products for ROM {Rupture of{fetal} Membrane}. Our diagnostic device solves the long-standing problem in obstetric practice diagnos more...
www.amnisure.com | Send Inquiry | Phone: +1-(617)-2344441
Quality: ISO13485:2003 Certified
Products: Non-invasive H Pylori Testing Kit, Track Etched Membranes, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Placental Alpha-1 Microglobulin (Pamg-1) Immunoassay (FDA Code: NQM), Barrier Membranes, ...
Amnisure International, LLC manufactures rapid and non-invasive test products for ROM {Rupture of{fetal} Membrane}. Our diagnostic device solves the long-standing problem in obstetric practice diagnos 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), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Blood Collection Systems (FDA Code: JKA), Electrolyte Control (FDA Code: JJR), Clinical Tonometer (FDA Code: LCH), Hematocrit Control (FDA Code: GLK), ...
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), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Blood Collection Systems (FDA Code: JKA), Electrolyte Control (FDA Code: JJR), Clinical Tonometer (FDA Code: LCH), Hematocrit Control (FDA Code: GLK), ...
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: Preps & Swabs, Cotton Swabs, Laboratory Centrifuges, Floor, Laboratory Information Systems (LIS), Software, Clinical Laboratory Information Systems (LIS), Benchtop Centrifuges, ...
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: Preps & Swabs, Cotton Swabs, Laboratory Centrifuges, Floor, Laboratory Information Systems (LIS), Software, Clinical Laboratory Information Systems (LIS), Benchtop Centrifuges, ...
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...
Waters Corp. | Address: 34 Maple St., Milford, Massachusetts 01757, USA
www.waters.com | Send Inquiry | Phone: +1-(508)-482-2000
FDA Registration: 1218959 Year Established: 1958 Annual Revenues: USD 100-500 Million Employee Count: ~4500 Quality: ISO 9002 Certified
Products: Liquid Chromatography, Liquid Chromatography Systems, General Tubing, Chromatography Column, Liquid Chromatography Equipment, Clinical Use Mass Spectrometer (FDA Code: DOP), ...
Waters Corp. creates business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality. Our more...
www.waters.com | Send Inquiry | Phone: +1-(508)-482-2000
FDA Registration: 1218959 Year Established: 1958 Annual Revenues: USD 100-500 Million Employee Count: ~4500 Quality: ISO 9002 Certified
Products: Liquid Chromatography, Liquid Chromatography Systems, General Tubing, Chromatography Column, Liquid Chromatography Equipment, Clinical Use Mass Spectrometer (FDA Code: DOP), ...
Waters Corp. creates business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality. Our 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), Creatinine Enzymatic Method Test (FDA Code: JFY), Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Glycosylated Hemoglobin Assay Test (FDA Code: LCP), C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK), ...
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), Creatinine Enzymatic Method Test (FDA Code: JFY), Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR), Glycosylated Hemoglobin Assay Test (FDA Code: LCP), C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK), ...
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...
Pharmacia Diagnostics AB | Address: 4169 Commercial Avenue, Portage, Michigan 49002, USA
www.phadia.us | Phone: +1-(800)-346-4364
FDA Registration: 9610566
Products: OSHA Compliance Training, Calibrators & Controls, Allergy, Allergy Kits Instruments, Allergy Reagents & Test Kits, Amylase Starch-Dye Bound Polymer Test (FDA Code: CIW), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Pharmacia Diagnostics AB concentrates in specific IgE blood testing to provide inspired, innovative allergy diagnostic solutions for laboratories. We developed and introduced vitro allergy testing to more...
www.phadia.us | Phone: +1-(800)-346-4364
FDA Registration: 9610566
Products: OSHA Compliance Training, Calibrators & Controls, Allergy, Allergy Kits Instruments, Allergy Reagents & Test Kits, Amylase Starch-Dye Bound Polymer Test (FDA Code: CIW), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Pharmacia Diagnostics AB concentrates in specific IgE blood testing to provide inspired, innovative allergy diagnostic solutions for laboratories. We developed and introduced vitro allergy testing to more...
R & D Systems, Inc. | Address: 614 McKinley Place N.E., Minneapolis, Minnesota 55413-2647, USA
www.rndsystems.com | Phone: +1-(800)-343-7475
FDA Registration: 2182501 Annual Revenues: USD 50-100 Million Employee Count: ~450
Products: Laboratory Reagent, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Cell Indices Calibrator (FDA Code: KRX), Hematology Quality Control Mixture (FDA Code: JPK), Hemoglobin Control (FDA Code: GGM), Microplate, ...
R & D Systems, Inc. manufactures reagents for the research and hematology markets. We also offer controls and calibrators for hematology analyzers. Our products include proteins, antibodies, assay kit more...
www.rndsystems.com | Phone: +1-(800)-343-7475
FDA Registration: 2182501 Annual Revenues: USD 50-100 Million Employee Count: ~450
Products: Laboratory Reagent, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Cell Indices Calibrator (FDA Code: KRX), Hematology Quality Control Mixture (FDA Code: JPK), Hemoglobin Control (FDA Code: GGM), Microplate, ...
R & D Systems, Inc. manufactures reagents for the research and hematology markets. We also offer controls and calibrators for hematology analyzers. Our products include proteins, antibodies, assay kit more...
Arkray Factory USA, Inc. | Address: 5182 West 76th St., Minneapolis, Minnesota 55439, USA
Phone: +1-(952)-646-3168
FDA Registration: 1832816
Products: Blood Lancets, Blood Lancet Needle (Pen Type), Blood Lancet Needle (Blade Type), Stainless Steel Blood Lancets, Plastic Blood Lancets, Blood Collection Lancet (FDA Code: FMK), ...
Arkray Factory USA, Inc. is engaged in the production of medical and surgical equipments. Our product line includes urine test strips, urine chemistry analyzers, intravascular catheters and blood gluc more...
Phone: +1-(952)-646-3168
FDA Registration: 1832816
Products: Blood Lancets, Blood Lancet Needle (Pen Type), Blood Lancet Needle (Blade Type), Stainless Steel Blood Lancets, Plastic Blood Lancets, Blood Collection Lancet (FDA Code: FMK), ...
Arkray Factory USA, Inc. is engaged in the production of medical and surgical equipments. Our product line includes urine test strips, urine chemistry analyzers, intravascular catheters and blood gluc more...
Biomerieux Industry | Address: 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA
www.biomerieux-usa.com | Send Inquiry | Phone: +1-(314)-731-8500, 800-634-7656
FDA Registration: 8020790 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: CE Certified
Products: Laboratory Equipment, Coagulation Lab Testing, Immunoassay Analyzers, Microbiology Kit, General Diagnostics, Automated Hematology Analyzers, ...
Biomerieux Industry provides in vitro diagnostics solutions for medical and industrial applications. We assist in the diagnosis of infectious diseases, such as hepatitis, HIV, tuberculosis and respira more...
www.biomerieux-usa.com | Send Inquiry | Phone: +1-(314)-731-8500, 800-634-7656
FDA Registration: 8020790 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: CE Certified
Products: Laboratory Equipment, Coagulation Lab Testing, Immunoassay Analyzers, Microbiology Kit, General Diagnostics, Automated Hematology Analyzers, ...
Biomerieux Industry provides in vitro diagnostics solutions for medical and industrial applications. We assist in the diagnosis of infectious diseases, such as hepatitis, HIV, tuberculosis and respira more...
Streck Labs, Inc | Address: 7002 South 109th Street, Omaha, Nebraska 68128, USA
www.streck.com | Send Inquiry | Phone: +1-(800)-843-0912
FDA Registration: 1950302 Year Established: 1971 Annual Revenues: USD 25-50 Million Employee Count: ~290 Quality: ISO 9001 Certified
Products: Thermometers, Calibrators, Calibrators for Equipment, Controls, Controls for Diagnostic Equipment, Diabetic Monitoring, ...
Streck Labs, Inc focuses on the area of cell stabilization & preservation, flow cytometry controls & preservatives, chemistry controls, a sedimentation rate product line and quality control devices. W more...
www.streck.com | Send Inquiry | Phone: +1-(800)-843-0912
FDA Registration: 1950302 Year Established: 1971 Annual Revenues: USD 25-50 Million Employee Count: ~290 Quality: ISO 9001 Certified
Products: Thermometers, Calibrators, Calibrators for Equipment, Controls, Controls for Diagnostic Equipment, Diabetic Monitoring, ...
Streck Labs, Inc focuses on the area of cell stabilization & preservation, flow cytometry controls & preservatives, chemistry controls, a sedimentation rate product line and quality control devices. W 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.
