Multi Analyte Control Suppliers
Limit companies to: Worldwide USA
Teco Diagnostics | Address: 1268 N. Lakeview Ave, Anaheim, California 92807, USA 
www.tecodiag.com | Send Inquiry | Phone: +1-(714)-463-111, 800-222-9880
FDA Registration: 1832216
Products: Serum Total Protein, ALT (SGPT), Gamma-GT, Amylase, Creatinine, Creatine Kinase (CK), ...
Teco Diagnostics is an ISO 13485 certified company. We offer a complete line of clinical chemistry reagents and urine reagent strips. Our one step pregnancy card test helps in obtaining a visual quali more...
www.tecodiag.com | Send Inquiry | Phone: +1-(714)-463-111, 800-222-9880
FDA Registration: 1832216
Products: Serum Total Protein, ALT (SGPT), Gamma-GT, Amylase, Creatinine, Creatine Kinase (CK), ...
Teco Diagnostics is an ISO 13485 certified company. We offer a complete line of clinical chemistry reagents and urine reagent strips. Our one step pregnancy card test helps in obtaining a visual quali more...
Bio-Rad Laboratories, Inc. | Address: 1000 Alfred Nobel Drive, Hercules, California 94547, USA
www.bio-rad.com | Send Inquiry | Phone: +1-(510)-724-7000
FDA Registration: 2915274 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~4300 Quality: ISO 9000, ISO 9001, CE Certified
Products: Plasma Protein Analyzers, HIV Screening - Western Blot, Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, Sterile Non-Barrier Pipette Tips, ...
Bio-Rad Laboratories, Inc. deals with life science research, clinical diagnostics, spectroscopy, process separations, and life science education. Our clinical diagnostics category deals with products more...
www.bio-rad.com | Send Inquiry | Phone: +1-(510)-724-7000
FDA Registration: 2915274 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~4300 Quality: ISO 9000, ISO 9001, CE Certified
Products: Plasma Protein Analyzers, HIV Screening - Western Blot, Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, Sterile Non-Barrier Pipette Tips, ...
Bio-Rad Laboratories, Inc. deals with life science research, clinical diagnostics, spectroscopy, process separations, and life science education. Our clinical diagnostics category deals with products more...
Osmetech, Inc. | Address: 757 S. Raymond Avenue, Pasadena, California 91105, USA
www.osmetech.com | Send Inquiry | Phone: +1-(770)-510-4444
Year Established: 1993
Products: Blood Gas Analyzers, Glucose, Catheters, Glucose Analyzers, Glucose Test Kits, Oximeters (FDA Code: DQA), ...
Osmetech focuses on providing cutting-edge, cost effective molecular diagnostic technologies. We offer products like eSensorr XT-8, eSensorr CFCD & SensiTubeT. The FDA cleared eSensorr CF carrier dete more...
www.osmetech.com | Send Inquiry | Phone: +1-(770)-510-4444
Year Established: 1993
Products: Blood Gas Analyzers, Glucose, Catheters, Glucose Analyzers, Glucose Test Kits, Oximeters (FDA Code: DQA), ...
Osmetech focuses on providing cutting-edge, cost effective molecular diagnostic technologies. We offer products like eSensorr XT-8, eSensorr CFCD & SensiTubeT. The FDA cleared eSensorr CF carrier dete more...
Quidel Corporation | Address: 10165 McKellar Court, San Diego, California 92121, USA
www.quidel.com | Send Inquiry | Phone: +1-(800)-874-1517
FDA Registration: 1528450 Year Established: 1979
Products: CIC (C1-q), Urine Chemistry Analyzers, Influenza A, B Test Kits, Mononucleosis Antibody (MONO) Test Kits, Helicobacter pylori Antibody Kits, Amines Test Kits, ...
Quidel Corporation manufactures & markets point-of-care (POC) rapid diagnostic tests for the detection & management of a variety of medical conditions and illnesses. We concentrate on women's and fami more...
www.quidel.com | Send Inquiry | Phone: +1-(800)-874-1517
FDA Registration: 1528450 Year Established: 1979
Products: CIC (C1-q), Urine Chemistry Analyzers, Influenza A, B Test Kits, Mononucleosis Antibody (MONO) Test Kits, Helicobacter pylori Antibody Kits, Amines Test Kits, ...
Quidel Corporation manufactures & markets point-of-care (POC) rapid diagnostic tests for the detection & management of a variety of medical conditions and illnesses. We concentrate on women's and fami more...
Biosite Incorporated | Address: 11030 Roselle Street, San Diego, California 92121, USA
www.biosite.com | Phone: +1-(858)-455-4808
FDA Registration: 2027969
Products: Myoglobin (FDA Code: DDR), B-Type Natriuretic Peptide (BNP), Clostridium difficile Test Kits, POC Cardiac Marker Analyzers, Microbiology Kit, General Diagnostic Supplies, ...
Biosite Incorporated is a bio-medical company commercializing proteomics discoveries for the advancement of medical diagnosis. We offer products such as drug testing, cardiovascular diseases, infectio more...
www.biosite.com | Phone: +1-(858)-455-4808
FDA Registration: 2027969
Products: Myoglobin (FDA Code: DDR), B-Type Natriuretic Peptide (BNP), Clostridium difficile Test Kits, POC Cardiac Marker Analyzers, Microbiology Kit, General Diagnostic Supplies, ...
Biosite Incorporated is a bio-medical company commercializing proteomics discoveries for the advancement of medical diagnosis. We offer products such as drug testing, cardiovascular diseases, infectio more...
Scantibodies Laboratory, Inc. | Address: 9336 Abraham Way, Santee, California 92017, USA
www.scantibodies.com | Send Inquiry | Phone: +1-(619)-258-9300
FDA Registration: 2020808
Products: Calcitonin, Intact PTH, calcitonin nasal Spray, Calcitonin Assay Immunoradiometric (IRMA) Assay, Calcitonin RIA Kit, Calcitonin ELISA Kit, ...
Scantibodies Laboratory, Inc. delivers diagnostic products. Our product line comprises of antibodies, blockers, controls, kits and plasma/serum. more...
www.scantibodies.com | Send Inquiry | Phone: +1-(619)-258-9300
FDA Registration: 2020808
Products: Calcitonin, Intact PTH, calcitonin nasal Spray, Calcitonin Assay Immunoradiometric (IRMA) Assay, Calcitonin RIA Kit, Calcitonin ELISA Kit, ...
Scantibodies Laboratory, Inc. delivers diagnostic products. Our product line comprises of antibodies, blockers, controls, kits and plasma/serum. more...
Abaxis, Inc | Address: 3240 Whipple Road, Union City, California 94587, USA
www.abaxis.com | Send Inquiry | Phone: +1-(510)-675-6500
FDA Registration: 2939693 Year Established: 1989 Annual Revenues: USD 25-50 Million Employee Count: ~260 Quality: ISO 9001 Certified
Products: Glucose, Microhematocrit Centrifuges, Glucose Analyzers, Lipid Panel and Triglyceride Analyzers, Glucose Test Kits, Centrifuges, ...
Abaxis, Inc supplies point of care blood analyzers to the medical market. We are an ISO 9001 certified company. We offer products to military, physician offices, hospitals, urgent care clinics and onc more...
www.abaxis.com | Send Inquiry | Phone: +1-(510)-675-6500
FDA Registration: 2939693 Year Established: 1989 Annual Revenues: USD 25-50 Million Employee Count: ~260 Quality: ISO 9001 Certified
Products: Glucose, Microhematocrit Centrifuges, Glucose Analyzers, Lipid Panel and Triglyceride Analyzers, Glucose Test Kits, Centrifuges, ...
Abaxis, Inc supplies point of care blood analyzers to the medical market. We are an ISO 9001 certified company. We offer products to military, physician offices, hospitals, urgent care clinics and onc more...
Awareness Technology, Inc. | Address: PO Drawer 1679, Palm City, Florida 34991, USA
www.awaretech.com | Send Inquiry | Phone: +1-(772)-283-6540
FDA Registration: 1036223 Year Established: 1982 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Microplate Washers, Incubator Shakers, Strip Readers, Plate Readers, Multi-Label Microplate Readers, Chemistry Analyzers, ...
Awareness Technology, Inc. designs & manufactures cost-effective laboratory instruments including chemistry analyzers, microplate readers, microplate washers and related laboratory equipment. Our Stat more...
www.awaretech.com | Send Inquiry | Phone: +1-(772)-283-6540
FDA Registration: 1036223 Year Established: 1982 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Microplate Washers, Incubator Shakers, Strip Readers, Plate Readers, Multi-Label Microplate Readers, Chemistry Analyzers, ...
Awareness Technology, Inc. designs & manufactures cost-effective laboratory instruments including chemistry analyzers, microplate readers, microplate washers and related laboratory equipment. Our Stat more...
Siemens Healthcare Diagnostics | Address: 1717 Deerfield Road, Deerfield, Illinois 60015-0778, USA
www.usa.siemens.com/diagnostics | Phone: +1-(847)-267-5300
Quality: ISO 9000, CE Certified
Products: Laboratory Automation Systems, Biochemistry Analyzers, Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Immunoassay Systems, Immunochemistry Analyzers, ...
Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehen more...
www.usa.siemens.com/diagnostics | Phone: +1-(847)-267-5300
Quality: ISO 9000, CE Certified
Products: Laboratory Automation Systems, Biochemistry Analyzers, Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Immunoassay Systems, Immunochemistry Analyzers, ...
Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehen more...
Polymer Technology Systems Inc. | Address: 7736 Zionsville Road, Indianapolis, Indiana 46268, USA
www.ptspanels.com | Send Inquiry | Phone: +1-(317)-870-5610
FDA Registration: 1836135
Products: Ketone Analyzers, Glucose Analyzers, Cholesterol Analyzers, Lipid Panel and Triglyceride Analyzers, Blood Collect Tubes, Chemistry Analyzers, ...
Polymer Technology Systems Inc. applies advanced diagnostic technology to supply tools for information about indicators of heart, cardiovascular disease and other diseases. We offer products such as c more...
www.ptspanels.com | Send Inquiry | Phone: +1-(317)-870-5610
FDA Registration: 1836135
Products: Ketone Analyzers, Glucose Analyzers, Cholesterol Analyzers, Lipid Panel and Triglyceride Analyzers, Blood Collect Tubes, Chemistry Analyzers, ...
Polymer Technology Systems Inc. applies advanced diagnostic technology to supply tools for information about indicators of heart, cardiovascular disease and other diseases. We offer products such as c more...
Remel | Address: 12076 Santa Fe Drive, P.O. Box 14428, Lenexa, Kansas 66215, USA
www.remelinc.com | Send Inquiry | Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973 Employee Count: ~20
Products: Swabs, Chemical Sterilizers (FDA Code: MLR), Coagulation Analyzers (FDA Code: GKP), Myoglobin (FDA Code: DDR), Sliding Microtomes (FDA Code: KFL), Rotary Microtomes (FDA Code: IDO), ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing more...
www.remelinc.com | Send Inquiry | Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973 Employee Count: ~20
Products: Swabs, Chemical Sterilizers (FDA Code: MLR), Coagulation Analyzers (FDA Code: GKP), Myoglobin (FDA Code: DDR), Sliding Microtomes (FDA Code: KFL), Rotary Microtomes (FDA Code: IDO), ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing more...
Hemagen Diagnostics, Inc. | Address: 9033 Red Branch Road, Columbia, Maryland 21045, USA
www.hemagen.com | Send Inquiry | Phone: +1-(443)-367-5500
FDA Registration: 1181055
Products: Bilirubin, Urea, Serum Total Protein, ALT (SGPT), Calcium, Gamma-GT, ...
Hemagen Diagnostics, Inc. offers diagnostic test kits. We develop, manufacture and supply test kits used in the diagnosis of certain autoimmune & infectious diseases. Our Virgor ENA screen 6 kit is an more...
www.hemagen.com | Send Inquiry | Phone: +1-(443)-367-5500
FDA Registration: 1181055
Products: Bilirubin, Urea, Serum Total Protein, ALT (SGPT), Calcium, Gamma-GT, ...
Hemagen Diagnostics, Inc. offers diagnostic test kits. We develop, manufacture and supply test kits used in the diagnosis of certain autoimmune & infectious diseases. Our Virgor ENA screen 6 kit is an more...
Genzyme Biosurgery | Address: 500 Kendall Street, Cambridge, Massachusetts 02142, USA
www.genzymebiosurgery.com | Send Inquiry | Phone: +1-(617)-252-7500
FDA Registration: 2246315 Employee Count: ~10000 Quality: CE Certified
Products: Skin Grafting Instruments, Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, ...
Genzyme Biosurgery develops novel biotherapeutic and biomaterial products. Our products and research pipeline harness the power of biology to improve the health of patients in the orthopaedics & post- more...
www.genzymebiosurgery.com | Send Inquiry | Phone: +1-(617)-252-7500
FDA Registration: 2246315 Employee Count: ~10000 Quality: CE Certified
Products: Skin Grafting Instruments, Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, ...
Genzyme Biosurgery develops novel biotherapeutic and biomaterial products. Our products and research pipeline harness the power of biology to improve the health of patients in the orthopaedics & post- more...
Diamond Diagnostics, Inc | Address: 333 Fiske Street, Holliston, Massachusetts 01746, USA
www.diamonddiagnostics.com | Send Inquiry | Phone: +1-(508)-429-0450
FDA Registration: 3003030793
Products: General Diagnostic Supplies, General Medical Supplies, Multi Analyte Control (FDA Code: JJY), Blood Gas Controls (FDA Code: JJS), Calcium Ion Specific Electrode (FDA Code: JFP), Multi Analyte Mixture - Calibrator (FDA Code: JIX), ...
Diamond Diagnostics, Inc supplies refurbished equipment and alternate brand supplies. We render small to mid-sized laboratories a reliable & cost effective alternative to new instrumentation. It is gi more...
www.diamonddiagnostics.com | Send Inquiry | Phone: +1-(508)-429-0450
FDA Registration: 3003030793
Products: General Diagnostic Supplies, General Medical Supplies, Multi Analyte Control (FDA Code: JJY), Blood Gas Controls (FDA Code: JJS), Calcium Ion Specific Electrode (FDA Code: JFP), Multi Analyte Mixture - Calibrator (FDA Code: JIX), ...
Diamond Diagnostics, Inc supplies refurbished equipment and alternate brand supplies. We render small to mid-sized laboratories a reliable & cost effective alternative to new instrumentation. It is gi more...
Instrumentation Laboratory (IL) | Address: 101 Hartwell Avenue, Lexington, Massachusetts 02421-3125, USA
www.ilus.com | Send Inquiry | Phone: +1-(781)-861-0710
FDA Registration: 1217183 Year Established: 1959 Annual Revenues: USD 50-100 Million Employee Count: ~300
Products: Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Automated Coagulation Analyzer (FDA Code: GKP), Automated Coagulation Instrument (FDA Code: GKP), Blood Clot Coagulation Analyzer (FDA Code: GKP), Coagulation Analyzer with Timer (FDA Code: GKP), ...
Instrumentation Laboratory (IL) manufactures and supplies critical care diagnostic & hemostasis instruments. We offer products like haemostatisis diagnostics, critical care diagnostics & acc trak. In more...
www.ilus.com | Send Inquiry | Phone: +1-(781)-861-0710
FDA Registration: 1217183 Year Established: 1959 Annual Revenues: USD 50-100 Million Employee Count: ~300
Products: Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Automated Coagulation Analyzer (FDA Code: GKP), Automated Coagulation Instrument (FDA Code: GKP), Blood Clot Coagulation Analyzer (FDA Code: GKP), Coagulation Analyzer with Timer (FDA Code: GKP), ...
Instrumentation Laboratory (IL) manufactures and supplies critical care diagnostic & hemostasis instruments. We offer products like haemostatisis diagnostics, critical care diagnostics & acc trak. In more...
Nova Biomedical | Address: 200 Prospect Street, Waltham, Massachusetts 02454-9141, USA
www.novabiomedical.com | Send Inquiry | Phone: +1-(781)-894-0800
FDA Registration: 1219029 Year Established: 1976 Annual Revenues: USD 100-500 Million Employee Count: ~620 Quality: ISO 9001, CE Certified
Products: Biochemistry Analyzers, Blood Gas Analyzers, Glucose, Glucose Analyzers, Glucose Test Kits, Glucose Monitoring Systems, ...
Nova Biomedical specializes in biosensor technology. We produce whole blood analyzers to support the care of critically ill patients. Our stat profile pHOx series analyzers offer essential blood gas a more...
www.novabiomedical.com | Send Inquiry | Phone: +1-(781)-894-0800
FDA Registration: 1219029 Year Established: 1976 Annual Revenues: USD 100-500 Million Employee Count: ~620 Quality: ISO 9001, CE Certified
Products: Biochemistry Analyzers, Blood Gas Analyzers, Glucose, Glucose Analyzers, Glucose Test Kits, Glucose Monitoring Systems, ...
Nova Biomedical specializes in biosensor technology. We produce whole blood analyzers to support the care of critically ill patients. Our stat profile pHOx series analyzers offer essential blood gas a more...
Inverness Medical Innovations, Inc. | Address: 51 Sawyer Rd., Suite 200, Waltham, Massachusetts 02453-3448, USA
www.invernessmedical.com | Send Inquiry | Phone: +1-(781)-647-3900
FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
Products: Myoglobin (FDA Code: DDR), Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Influenza A and B Testing rapid Influenza Testing, Automated Urinalysis System (FDA Code: KQO), ...
Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
www.invernessmedical.com | Send Inquiry | Phone: +1-(781)-647-3900
FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
Products: Myoglobin (FDA Code: DDR), Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Influenza A and B Testing rapid Influenza Testing, Automated Urinalysis System (FDA Code: KQO), ...
Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
Pointe Scientific, Inc. | Address: 5449 Research Drive, Canton, Michigan 48188, USA
www.pointescientific.com | Send Inquiry | Phone: +1-(734)-487-8300
FDA Registration: 1827821 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: CE Certified
Products: Ferritin (FDA Code: DBF), Hemoglobin A1C (Glycohemoglobin), Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin), Biopotential Amplifier and Signal Conditioner (FDA Code: DRR), Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), ...
Pointe Scientific, Inc. manufactures clinical diagnostic products. We offer products such as general chemistry, analyzer/instruments, standard calibrators, specific reagents, EIA, serology, urine chem more...
www.pointescientific.com | Send Inquiry | Phone: +1-(734)-487-8300
FDA Registration: 1827821 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: CE Certified
Products: Ferritin (FDA Code: DBF), Hemoglobin A1C (Glycohemoglobin), Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin), Biopotential Amplifier and Signal Conditioner (FDA Code: DRR), Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), ...
Pointe Scientific, Inc. manufactures clinical diagnostic products. We offer products such as general chemistry, analyzer/instruments, standard calibrators, specific reagents, EIA, serology, urine chem more...
Fisher Scientific International, Inc. | Address: Liberty Lane, Hampton, New Hampshire 03842, USA
www.fisherscientific.com | Send Inquiry | Phone: +1-(603)-926-5911
FDA Registration: 2431530 Annual Revenues: USD 50-100 Million Employee Count: ~3300
Products: Hypodermic Needles, Hypodermic Syringes, Colony Counters, Slide Staining, Gastroenterologic Needle Holder (FDA Code: FHQ), Iris Scissors, ...
Fisher Scientific International, Inc. provides products & services to the scientific research community & clinical laboratories. We manufacture and distribute a wide array of diagnostic kits & reagent more...
www.fisherscientific.com | Send Inquiry | Phone: +1-(603)-926-5911
FDA Registration: 2431530 Annual Revenues: USD 50-100 Million Employee Count: ~3300
Products: Hypodermic Needles, Hypodermic Syringes, Colony Counters, Slide Staining, Gastroenterologic Needle Holder (FDA Code: FHQ), Iris Scissors, ...
Fisher Scientific International, Inc. provides products & services to the scientific research community & clinical laboratories. We manufacture and distribute a wide array of diagnostic kits & reagent more...
Abbott Point of Care Inc. | Address: 400 College Road East, Princeton, New Jersey 08540, USA
www.abbottpointofcare.com | Phone: +1-(800)-827-7828
FDA Registration: 2245578 Annual Revenues: USD 50-100 Million Employee Count: ~480 Quality: ISO 9001, ISO 9003, CE Certified
Products: Micro Surgery Instruments, Blood Gas Analyzers, Capillary Blood Collection Tubes (FDA Code: GIO), Micro Surgery Instruments, Pneumatic Power Systems, Micro Surgery Instruments, Graspers, Micro Surgery Instruments, Scissors, ...
Abbott Point of Care Inc. deals with analyzers and cartridges. Our i-STAT® 1 analyzer is a handheld system that performs a comprehensive panel of critical tests. It utilizes self-contained test ca more...
www.abbottpointofcare.com | Phone: +1-(800)-827-7828
FDA Registration: 2245578 Annual Revenues: USD 50-100 Million Employee Count: ~480 Quality: ISO 9001, ISO 9003, CE Certified
Products: Micro Surgery Instruments, Blood Gas Analyzers, Capillary Blood Collection Tubes (FDA Code: GIO), Micro Surgery Instruments, Pneumatic Power Systems, Micro Surgery Instruments, Graspers, Micro Surgery Instruments, Scissors, ...
Abbott Point of Care Inc. deals with analyzers and cartridges. Our i-STAT® 1 analyzer is a handheld system that performs a comprehensive panel of critical tests. It utilizes self-contained test ca 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.
