Assayed and Unassayed Single (Specified) Analyte Controls Suppliers
Limit companies to: Worldwide USA
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...
Polymedco Inc. | Address: 510 Furnace Dock Road, Cortlandt Manor, New York 10567, USA
www.polymedco.com | Send Inquiry | Phone: +1-(914)-739-5400
FDA Registration: 2435505 Year Established: 1980 Annual Revenues: USD 10-25 Million Employee Count: ~50
Products: Hematology Analyzers, Erythrocyte Sedimentation Rate (ESR) Test Kits, Bladder Tumor Antigen (NMP22) Test Kits, Streptococcus Test Kits, Bladder Cancer Tests, Chemistry Analyzers, ...
Polymedco Inc. introduced a magnetic separation method for HDL which is better than the conventional testing means for cholesterol. We introduced Sed-Chek® 2 ESR control which helps in sedrate con more...
www.polymedco.com | Send Inquiry | Phone: +1-(914)-739-5400
FDA Registration: 2435505 Year Established: 1980 Annual Revenues: USD 10-25 Million Employee Count: ~50
Products: Hematology Analyzers, Erythrocyte Sedimentation Rate (ESR) Test Kits, Bladder Tumor Antigen (NMP22) Test Kits, Streptococcus Test Kits, Bladder Cancer Tests, Chemistry Analyzers, ...
Polymedco Inc. introduced a magnetic separation method for HDL which is better than the conventional testing means for cholesterol. We introduced Sed-Chek® 2 ESR control which helps in sedrate con more...
Olympus America, Inc. | Address: P.O. BOX 9058,2 Corporate Center Drive, Melville, New York 11747-9058, USA
www.olympusamerica.com/msg_section/msg_home.asp | Phone: +1-(631)-844-5000
FDA Registration: 2429304 Year Established: 1919 Annual Revenues: > USD 1 Billion Employee Count: ~700
Products: Light Sources, Endoscopy Recording Systems, Myoglobin (FDA Code: DDR), Endoscopic Ultrasound, Arthroscopes (FDA Code: HRX), Ferritin (FDA Code: DBF), ...
Olympus America, Inc. provides portable intubation fiberoscope, standard intubation fiberscope, bronchoscope, colonoscope, gastroscope, enteroscope, duodenoscope, sigmoidoscope, choledoscope, endoscop more...
www.olympusamerica.com/msg_section/msg_home.asp | Phone: +1-(631)-844-5000
FDA Registration: 2429304 Year Established: 1919 Annual Revenues: > USD 1 Billion Employee Count: ~700
Products: Light Sources, Endoscopy Recording Systems, Myoglobin (FDA Code: DDR), Endoscopic Ultrasound, Arthroscopes (FDA Code: HRX), Ferritin (FDA Code: DBF), ...
Olympus America, Inc. provides portable intubation fiberoscope, standard intubation fiberscope, bronchoscope, colonoscope, gastroscope, enteroscope, duodenoscope, sigmoidoscope, choledoscope, endoscop more...
Ortho-clinical Diagnostics, Inc. | Address: 100 Indigo Creek Drive, Rochester, New York 14626, USA
www.orthoclinical.com | Send Inquiry | Phone: +1-(800)-828-6316
FDA Registration: 1319809 Year Established: 1937
Products: Laboratory Automation Systems, Immunoassay Systems, Troponin I, Myoglobin (FDA Code: DDR), Glucose Analyzers, Glucose Test Kits, ...
Ortho-clinical Diagnostics, Inc. provides diagnostic products and services for the global health care community. We deliver accurate, timely & cost-effective solutions for screening, diagnosing, monit more...
www.orthoclinical.com | Send Inquiry | Phone: +1-(800)-828-6316
FDA Registration: 1319809 Year Established: 1937
Products: Laboratory Automation Systems, Immunoassay Systems, Troponin I, Myoglobin (FDA Code: DDR), Glucose Analyzers, Glucose Test Kits, ...
Ortho-clinical Diagnostics, Inc. provides diagnostic products and services for the global health care community. We deliver accurate, timely & cost-effective solutions for screening, diagnosing, monit more...
Helena Laboratories Corp. | Address: P. O. Box 752, Beaumont, Texas 77704-0752, USA
www.helena.com | Send Inquiry | Phone: +1-(409)-842-3714, 800-231-5663
FDA Registration: 3011390138 Year Established: 1966 Annual Revenues: USD 50-100 Million Employee Count: ~1000 Quality: ISO 9001, CE Certified
Products: Laboratory Equipment, Coagulation Analyzers (FDA Code: GKP), POC Coagulation Analyzers (PT and INR), Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, ...
Helena Laboratories Corp. develops new diagnostic tests. We manufacture electrophoresis analyzers, test kits for fecal occult blood, immunology and protein diagnostics, and hemostasis reagents & instr more...
www.helena.com | Send Inquiry | Phone: +1-(409)-842-3714, 800-231-5663
FDA Registration: 3011390138 Year Established: 1966 Annual Revenues: USD 50-100 Million Employee Count: ~1000 Quality: ISO 9001, CE Certified
Products: Laboratory Equipment, Coagulation Analyzers (FDA Code: GKP), POC Coagulation Analyzers (PT and INR), Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, ...
Helena Laboratories Corp. develops new diagnostic tests. We manufacture electrophoresis analyzers, test kits for fecal occult blood, immunology and protein diagnostics, and hemostasis reagents & instr more...
Stanbio Laboratory | Address: 1261,North Main Street, Boerne, Texas 78006, USA
www.stanbio.com | Send Inquiry | Phone: +1-(830)-249-0772
FDA Registration: 1616487 Year Established: 1960 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Hemoglobin Testing Systems, Alkaline Phosphatase (ALP) (FDA Code: JCJ), Hemoglobin Analyzers, Streptococcus Test Kits, Coagulation Lab Testing, Infectious Disease Exams, ...
Stanbio Laboratory is a developer, manufacturer and distributor clinical diagnostic products. Our UriTrak™ 100 analyzer is an economical system that offers physician offices & laboratories the a more...
www.stanbio.com | Send Inquiry | Phone: +1-(830)-249-0772
FDA Registration: 1616487 Year Established: 1960 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Hemoglobin Testing Systems, Alkaline Phosphatase (ALP) (FDA Code: JCJ), Hemoglobin Analyzers, Streptococcus Test Kits, Coagulation Lab Testing, Infectious Disease Exams, ...
Stanbio Laboratory is a developer, manufacturer and distributor clinical diagnostic products. Our UriTrak™ 100 analyzer is an economical system that offers physician offices & laboratories the a more...
SA Scientific, Inc. | Address: 4919 Golden Quail, San Antonio, Texas 78240, USA
www.sascientific.com | Send Inquiry | Phone: +1-(210)-699-8800
FDA Registration: 1645225 Year Established: 1984 Annual Revenues: USD 5-10 Million Employee Count: ~50
Products: Streptococcus Test Kits, Rotavirus Test Kits, General Diagnostic Supplies, Swabs, Streptococcus Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, ...
SA Scientific, Inc. designs, develops & produces a wide range of one-step rapid tests for fertility & infectious diseases. We manufacture products to aid in the detection of pregnancy (hCG), ovulation more...
www.sascientific.com | Send Inquiry | Phone: +1-(210)-699-8800
FDA Registration: 1645225 Year Established: 1984 Annual Revenues: USD 5-10 Million Employee Count: ~50
Products: Streptococcus Test Kits, Rotavirus Test Kits, General Diagnostic Supplies, Swabs, Streptococcus Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, ...
SA Scientific, Inc. designs, develops & produces a wide range of one-step rapid tests for fertility & infectious diseases. We manufacture products to aid in the detection of pregnancy (hCG), ovulation more...
Wescor Inc. | Address: 370 West 1700 South, Logan, Utah 84321, USA
www.wescor.com | Send Inquiry | Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Programmable Slide Stainers, Hematology Slide Stainer Instruments, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos more...
www.wescor.com | Send Inquiry | Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Programmable Slide Stainers, Hematology Slide Stainer Instruments, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos more...
Wako Diagnostics | Address: 1600 Bellwood Road, Richmond, Virginia 23237, USA
www.wakousa.com | Send Inquiry | Phone: +1-(804)-714-1924
FDA Registration: 1627434 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: C-Reactive Protein (CRP), General Chemistry Calibrators, General Chemistry Test Kits, Cardiac Markers kits, Immunoassays, Lipids Test Kits, ...
Wako Diagnostics develops high purity chemicals. We are an ISO 9001 certified company. We are a comprehensive manufacturer of clinical diagnostic reagents that are of highest quality and extremely cos more...
www.wakousa.com | Send Inquiry | Phone: +1-(804)-714-1924
FDA Registration: 1627434 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: C-Reactive Protein (CRP), General Chemistry Calibrators, General Chemistry Test Kits, Cardiac Markers kits, Immunoassays, Lipids Test Kits, ...
Wako Diagnostics develops high purity chemicals. We are an ISO 9001 certified company. We are a comprehensive manufacturer of clinical diagnostic reagents that are of highest quality and extremely cos more...
Kamiya Biomedical Company | Address: 12779 Gateway Drive, Seattle, Washington 98168, USA
www.kamiyabiomedical.com | Send Inquiry | Phone: +1-(206)-575-8068
FDA Registration: 2084025 Year Established: 1983 Annual Revenues: USD 1-5 Million
Products: Ferritin (FDA Code: DBF), General Diagnostic Supplies, Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Ferritin Testing Kit, Gamma Dab Ferritin Kit, RIA Gnost Ferritin Kit, ...
Kamiya Biomedical Company supplies laboratory research & diagnostic tools to the life science and medical communities. We are an ISO 13485:2003 certified company. We offer products like calibrators, r more...
www.kamiyabiomedical.com | Send Inquiry | Phone: +1-(206)-575-8068
FDA Registration: 2084025 Year Established: 1983 Annual Revenues: USD 1-5 Million
Products: Ferritin (FDA Code: DBF), General Diagnostic Supplies, Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Ferritin Testing Kit, Gamma Dab Ferritin Kit, RIA Gnost Ferritin Kit, ...
Kamiya Biomedical Company supplies laboratory research & diagnostic tools to the life science and medical communities. We are an ISO 13485:2003 certified company. We offer products like calibrators, r more...
Lifescan LLC. | Address: Rd. 308 Km 0.8, Pedernales Industrial Park, Cabo Rojo 00623-5001, USA
Phone: +1-(408)-942-3589
Products: Dry Reagent Test Strips, Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Data Processing Module for Clinical use (FDA Code: JQP), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Lifescan LLC. offers reagent test strips for whole blood glucose determination. more...
Phone: +1-(408)-942-3589
Products: Dry Reagent Test Strips, Blood Collection Lancet (FDA Code: FMK), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Data Processing Module for Clinical use (FDA Code: JQP), Glucose Oxidase, Glucose (FDA Code: CGA), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), ...
Lifescan LLC. offers reagent test strips for whole blood glucose determination. more...
Diabetic Supply Of Suncoast, Inc. | Address: Bo. Espinosa Carr. 2km. 26.2, Colinas De Plata 00646, USA
www.dsosi.com | Phone: +1-(866)-607 1598
FDA Registration: 3005861699
Products: Blood Pressure Monitors, Lancets, Heating Pads, 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), ...
Diabetic Supply Of Suncoast, Inc. manufactures & distributes diabetic support equipments. We provide Advocate® speaking glucose monitor, blood pressure monitor & Advocate redicode™. We also more...
www.dsosi.com | Phone: +1-(866)-607 1598
FDA Registration: 3005861699
Products: Blood Pressure Monitors, Lancets, Heating Pads, 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), ...
Diabetic Supply Of Suncoast, Inc. manufactures & distributes diabetic support equipments. We provide Advocate® speaking glucose monitor, blood pressure monitor & Advocate redicode™. We also more...
Sanmina-SCI USA, Inc. | Address: 13000 South Memorial Pkwy., Huntsville, Alabama 35803, USA
Phone: +1-(256)-882-4800
FDA Registration: 1037998
Products: Oximeters (FDA Code: DQA), Glucose Monitoring Systems, Glucose Monitoring, Glucose Monitors, Autotransfusion Apparatus (FDA Code: CAC), Cardiac Monitor (Cardiotachometer and Rate Alarm) (FDA Code: DRT), ...
Sanmina-SCI USA, Inc. offers microwave hyperthermia systems, and glucose monitoring systems. more...
Phone: +1-(256)-882-4800
FDA Registration: 1037998
Products: Oximeters (FDA Code: DQA), Glucose Monitoring Systems, Glucose Monitoring, Glucose Monitors, Autotransfusion Apparatus (FDA Code: CAC), Cardiac Monitor (Cardiotachometer and Rate Alarm) (FDA Code: DRT), ...
Sanmina-SCI USA, Inc. offers microwave hyperthermia systems, and glucose monitoring systems. more...
Acrometrix | Address: 6010 Egret Ct., Benicia, California 94510, USA
www.acrometrix.com | Send Inquiry | Phone: +1-(707)-746-8888
Products: Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Test(Donors) Kit For Bloodborne Pathogen (FDA Code: MYZ), Multi-Analyte Controls Unassayed (FDA Code: OHQ), ...
Acrometrix offers a range of molecular products. The product range includes controls and standards to assist in the implementation & monitoring of diagnostic assays for clinical laboratories, blood ce more...
www.acrometrix.com | Send Inquiry | Phone: +1-(707)-746-8888
Products: Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Test(Donors) Kit For Bloodborne Pathogen (FDA Code: MYZ), Multi-Analyte Controls Unassayed (FDA Code: OHQ), ...
Acrometrix offers a range of molecular products. The product range includes controls and standards to assist in the implementation & monitoring of diagnostic assays for clinical laboratories, blood ce more...
Carolina Liquid Chemistries Corp. | Address: 510 West Central Ave., Suite C, Brea, California 92821, USA
carolinachemistries.com | Send Inquiry | Phone: +1-(800)-471-7272
FDA Registration: 2030861
Products: Alkaline Phosphatase (ALP) (FDA Code: JCJ), Calibrators for Equipment, Chemistry Analyzers, Controls, Cups, General Diagnostic Supplies, ...
Carolina Liquid Chemistries Corp. offers products for the medical industry. The new recombinant enzymatic cycling assay (RECA) offers an exceptionally fast and accurate method for performing homocyste more...
carolinachemistries.com | Send Inquiry | Phone: +1-(800)-471-7272
FDA Registration: 2030861
Products: Alkaline Phosphatase (ALP) (FDA Code: JCJ), Calibrators for Equipment, Chemistry Analyzers, Controls, Cups, General Diagnostic Supplies, ...
Carolina Liquid Chemistries Corp. offers products for the medical industry. The new recombinant enzymatic cycling assay (RECA) offers an exceptionally fast and accurate method for performing homocyste more...
Aalto Scientific Ltd | Address: 1959 Kellogg Ave, Carlsbad, California 92008, USA
www.aaltoscientific.com | Send Inquiry | Phone: +1-(800)-748-6674
FDA Registration: 3011325031 Year Established: 1979 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001 Certified
Products: Fertility Products, Serum Protein Substitute, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Electrolyte Control (FDA Code: JJR), Enzyme Controls (FDA Code: JJT), Alcohol Control Materials (FDA Code: DKC), ...
Aalto Scientific Ltd manufactures human sera. We supply human cardiac antigens, creatine kinase MM, MB and BB. more...
www.aaltoscientific.com | Send Inquiry | Phone: +1-(800)-748-6674
FDA Registration: 3011325031 Year Established: 1979 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001 Certified
Products: Fertility Products, Serum Protein Substitute, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Electrolyte Control (FDA Code: JJR), Enzyme Controls (FDA Code: JJT), Alcohol Control Materials (FDA Code: DKC), ...
Aalto Scientific Ltd manufactures human sera. We supply human cardiac antigens, creatine kinase MM, MB and BB. more...
Mardx Diagnostics, Inc. | Address: 5919 Farnsworth Ct., Carlsbad, California 92008, USA
Phone: +1-(760)-929-0500
FDA Registration: 2245544 Annual Revenues: USD 5-10 Million
Products: Coagulation Analyzers (FDA Code: GKP), Lyme Disease (Borrelia) Test Kits, Automated Coagulation Analyzer (FDA Code: GKP), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Infectious Disease Test Kits, Automated Coagulation Instrument (FDA Code: GKP), ...
Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclea more...
Phone: +1-(760)-929-0500
FDA Registration: 2245544 Annual Revenues: USD 5-10 Million
Products: Coagulation Analyzers (FDA Code: GKP), Lyme Disease (Borrelia) Test Kits, Automated Coagulation Analyzer (FDA Code: GKP), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Infectious Disease Test Kits, Automated Coagulation Instrument (FDA Code: GKP), ...
Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclea more...
Syntron Bioresearch, Inc. | Address: 2774 Loker Avenue W., Carlsbad, California 92008, USA
www.syntron.net | Send Inquiry | Phone: +1-(760)-930-2200, 800-854-6226
FDA Registration: 2025760 Year Established: 1986 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001 Certified
Products: Tumor Markers, Blood Glucose Test Strips, Cholesterol Test Kits, Thyroid Stimulating Hormone (TSH) EIA Test Kit, Automated Urinalysis System (FDA Code: KQO), Immunodiagnostic Test Kits, ...
Syntron Bioresearch, Inc. is a research, development and manufacturing company specializing in rapid in vitro immunodiagnostic test systems. We offer diagnostic products including tests for allergy, c more...
www.syntron.net | Send Inquiry | Phone: +1-(760)-930-2200, 800-854-6226
FDA Registration: 2025760 Year Established: 1986 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001 Certified
Products: Tumor Markers, Blood Glucose Test Strips, Cholesterol Test Kits, Thyroid Stimulating Hormone (TSH) EIA Test Kit, Automated Urinalysis System (FDA Code: KQO), Immunodiagnostic Test Kits, ...
Syntron Bioresearch, Inc. is a research, development and manufacturing company specializing in rapid in vitro immunodiagnostic test systems. We offer diagnostic products including tests for allergy, c more...
Aventir Biotech, LLC | Address: 3108 Avenida Olmeda, Carlsbad, California 92009, USA
www.aventirbio.com | Send Inquiry | Phone: +1-(760)-6022929
Products: Tumor Markers, Saliva Alcohol Test, Cancer Tumor Markers, Wrist Blood Pressure Monitors, Glucose Kits, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Aventir Biotech, LLC markets and distributes point-of-care, rapid diagnostic tests for the detection of medical conditions & illnesses. Our product range focuses on health check products, diabetic pro more...
www.aventirbio.com | Send Inquiry | Phone: +1-(760)-6022929
Products: Tumor Markers, Saliva Alcohol Test, Cancer Tumor Markers, Wrist Blood Pressure Monitors, Glucose Kits, Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Aventir Biotech, LLC markets and distributes point-of-care, rapid diagnostic tests for the detection of medical conditions & illnesses. Our product range focuses on health check products, diabetic pro more...
Dako North America, Inc. | Address: 6392 Via Real, Carpinteria, California 93013, USA
www.dakousa.com | Send Inquiry | Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO 9001 Certified
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Microscope Slides (FDA Code: KEW), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen more...
www.dakousa.com | Send Inquiry | Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO 9001 Certified
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Microscope Slides (FDA Code: KEW), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen 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.
