Multi Analyte Control Suppliers
Limit companies to: Worldwide USA
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...
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...
BD Diagnostics - TriPath | Address: 780 Plantation Drive, Burlington, North Carolina 27215, USA
www.tripathimaging.com | Send Inquiry | Phone: +1-(336)-222-9707
FDA Registration: 1062336
Products: Molecular Analyte Specific Reagents (ASR), Diagnostic Aids, Blood Analyzer Reagents, Calibrators, Calibrators for Equipment, Chemistry Analyzers, ...
BD Diagnostics - TriPath develops and distributes solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. Our BD ProEx™ C reagent is a high more...
www.tripathimaging.com | Send Inquiry | Phone: +1-(336)-222-9707
FDA Registration: 1062336
Products: Molecular Analyte Specific Reagents (ASR), Diagnostic Aids, Blood Analyzer Reagents, Calibrators, Calibrators for Equipment, Chemistry Analyzers, ...
BD Diagnostics - TriPath develops and distributes solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. Our BD ProEx™ C reagent is a high 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...
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...
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...
Sendx Med, Inc. | Address: 1945 Palomar Oaks Way, Carlsbad, California 92009, USA
Phone: +1-(760)-930-6300
FDA Registration: 2027541 Annual Revenues: < USD 1 Million
Products: Oximeters (FDA Code: DQA), Whole Blood Testing System, Arterial Blood Sampling Kit (FDA Code: CBT), Cutaneous Carbon-Dioxide Monitor (FDA Code: LKD), Cutaneous Oxygen Monitor for Infant (FDA Code: KLK), Ear Oximeter (FDA Code: DPZ), ...
Sendx Med, Inc. manufactures laboratory blood testing apparatus. more...
Phone: +1-(760)-930-6300
FDA Registration: 2027541 Annual Revenues: < USD 1 Million
Products: Oximeters (FDA Code: DQA), Whole Blood Testing System, Arterial Blood Sampling Kit (FDA Code: CBT), Cutaneous Carbon-Dioxide Monitor (FDA Code: LKD), Cutaneous Oxygen Monitor for Infant (FDA Code: KLK), Ear Oximeter (FDA Code: DPZ), ...
Sendx Med, Inc. manufactures laboratory blood testing apparatus. more...
Compass Bioscience | Address: 1850 Evergreen St., Duarte, California 91010-2906, USA
www.seraplex.com | Send Inquiry | Phone: +1-(626)-359-9645
Year Established: 1974 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO Certified
Products: Multi Analyte Control (FDA Code: JJY), Urinalysis Controls (FDA Code: JJW), ...
Compass Bioscience is a distributor of blood derivatives to the diagnostic and bio pharmaceutical community. We offer seraplex, compass and donor center products. The seraplex products are blood compo more...
www.seraplex.com | Send Inquiry | Phone: +1-(626)-359-9645
Year Established: 1974 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO Certified
Products: Multi Analyte Control (FDA Code: JJY), Urinalysis Controls (FDA Code: JJW), ...
Compass Bioscience is a distributor of blood derivatives to the diagnostic and bio pharmaceutical community. We offer seraplex, compass and donor center products. The seraplex products are blood compo more...
Cliniqa Corporation | Address: 1432 South Mission Road, Fallbrook, California 92028, USA
www.cliniqa.com | Send Inquiry | Phone: +1-(760)-744-1900, 800-728-5205
FDA Registration: 2085064 Year Established: 1975 Annual Revenues: USD 10-25 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Controls for Diagnostic Equipment, General Diagnostic Supplies, Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Polyclonal Antibody Goat Anti-whole hCG, Polyclonal Antibody Goat Anti-mouse IgG, Polyclonal Antibody Goat Anti-human IgG, ...
Cliniqa Corporation produces and markets high quality antiserum, proteins, liquid controls & calibrator products that are designed to improve the accuracy of diagnostic tests. Our Liquid QC™ Lin more...
www.cliniqa.com | Send Inquiry | Phone: +1-(760)-744-1900, 800-728-5205
FDA Registration: 2085064 Year Established: 1975 Annual Revenues: USD 10-25 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Controls for Diagnostic Equipment, General Diagnostic Supplies, Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Polyclonal Antibody Goat Anti-whole hCG, Polyclonal Antibody Goat Anti-mouse IgG, Polyclonal Antibody Goat Anti-human IgG, ...
Cliniqa Corporation produces and markets high quality antiserum, proteins, liquid controls & calibrator products that are designed to improve the accuracy of diagnostic tests. Our Liquid QC™ Lin more...
Beckman Coulter, Inc. | Address: 4300 N. Harbor Boulevard P.O. Box 3100, Fullerton, California 92834-3100, USA
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012 Year Established: 1934 Annual Revenues: > USD 1 Billion Employee Count: ~10100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood Glucose Meters, Blood Pressure Measuring Equipment, Fetal Monitors, Otoscopes, Blood Bags For Dialysis, Blood & Intravenous (IV) Bottles, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic more...
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012 Year Established: 1934 Annual Revenues: > USD 1 Billion Employee Count: ~10100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood Glucose Meters, Blood Pressure Measuring Equipment, Fetal Monitors, Otoscopes, Blood Bags For Dialysis, Blood & Intravenous (IV) Bottles, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic more...
Synergent Biochem, Inc. | Address: 12026 Centralia Ave., Unit G & H, Hawaiian Gardens, California 90716, USA
www.synergentbiochem.com | Send Inquiry | Phone: +1-(562)-809-3389
FDA Registration: 2032335 Year Established: 2000
Products: HDL/LDL Calibrator, 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 Control Materials (FDA Code: DIF), Urine DOA Screening Controls, ...
Synergent Biochem, Inc. designs and manufactures clinical chemistry, toxicology controls and calibrators for in vitro diagnostic marketplace. We offer drug of abuse and liquid lipid products. The drug more...
www.synergentbiochem.com | Send Inquiry | Phone: +1-(562)-809-3389
FDA Registration: 2032335 Year Established: 2000
Products: HDL/LDL Calibrator, 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 Control Materials (FDA Code: DIF), Urine DOA Screening Controls, ...
Synergent Biochem, Inc. designs and manufactures clinical chemistry, toxicology controls and calibrators for in vitro diagnostic marketplace. We offer drug of abuse and liquid lipid products. The drug more...
More Diagnostics, Inc. | Address: PO Box 6714, Los Osos, California 93412, USA
www.morediagnostics.com | Send Inquiry | Phone: +1-(805)-528-6005, 800-758-0978
FDA Registration: 2085085 Year Established: 1993 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Cardiac Markers, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Primary Calibrator (FDA Code: JIS), Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), ...
More Diagnostics, Inc. is a manufacturer and distributor of clinical diagnostic quality controls for cardiac markers, cyclosporine C2, mycophenolic acid, TAC/CsA and RAP/TAC/CsA, featuring reliable sp more...
www.morediagnostics.com | Send Inquiry | Phone: +1-(805)-528-6005, 800-758-0978
FDA Registration: 2085085 Year Established: 1993 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Cardiac Markers, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Primary Calibrator (FDA Code: JIS), Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), ...
More Diagnostics, Inc. is a manufacturer and distributor of clinical diagnostic quality controls for cardiac markers, cyclosporine C2, mycophenolic acid, TAC/CsA and RAP/TAC/CsA, featuring reliable sp more...
Clinical Controls International | Address: 2131 10th St, Suite B, Los Osos, California 93402, USA
www.clinicalcontrols.com | Send Inquiry | Phone: +1-(805)-528-4039
Products: General Chemistry Calibrators, Drugs Of Abuse Test Kits, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Enzyme Controls (FDA Code: JJT), Alcohol Control Materials (FDA Code: DKC), ...
Clinical Controls International offers custom formulations and specialty products, which include whole blood, serum and urine controls, internal and external proficiency performance programs & control more...
www.clinicalcontrols.com | Send Inquiry | Phone: +1-(805)-528-4039
Products: General Chemistry Calibrators, Drugs Of Abuse Test Kits, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), Enzyme Controls (FDA Code: JJT), Alcohol Control Materials (FDA Code: DKC), ...
Clinical Controls International offers custom formulations and specialty products, which include whole blood, serum and urine controls, internal and external proficiency performance programs & control more...
Biocell Laboratories, Inc. | Address: 2001 E. University Dr., Rancho Dominguez, California 90220-6411, USA
www.biocell.com | Send Inquiry | Phone: +1-(310)-537-3300, 800-222-8382
FDA Registration: 2077563 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Fertility Products, Human Serum Albumin, Cerebrospinal Fluid Reservoir, Spinal Fluid Reservoir, Human Serum, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Biocell Laboratories, Inc. provides plasma fractions, sera and custom products. We produce bovine serum albumin and bovine gamma globulin utilizing the Cohn cold ethanol precipitation process. We also more...
www.biocell.com | Send Inquiry | Phone: +1-(310)-537-3300, 800-222-8382
FDA Registration: 2077563 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001 Certified
Products: Fertility Products, Human Serum Albumin, Cerebrospinal Fluid Reservoir, Spinal Fluid Reservoir, Human Serum, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Biocell Laboratories, Inc. provides plasma fractions, sera and custom products. We produce bovine serum albumin and bovine gamma globulin utilizing the Cohn cold ethanol precipitation process. We also more...
Quantimetrix Corp | Address: 2005 Manhattan Beach Boulevard, Redondo Beach, California 90278, USA
www.4qc.com | Send Inquiry | Phone: +001-(310)-536-0006
Quality: ISO, CE Certified
Products: Glucose, Glucose Analyzers, Glucose Test Kits, Blood Collect Tubes, Controls for Diagnostic Equipment, Diabetic Monitoring, ...
Quantimetrix Corp manufactures clinical laboratory quality control products. Our Dipper™ urine dipstick control is designed to validate visual & instrumental readings of urine dipsticks by immer more...
www.4qc.com | Send Inquiry | Phone: +001-(310)-536-0006
Quality: ISO, CE Certified
Products: Glucose, Glucose Analyzers, Glucose Test Kits, Blood Collect Tubes, Controls for Diagnostic Equipment, Diabetic Monitoring, ...
Quantimetrix Corp manufactures clinical laboratory quality control products. Our Dipper™ urine dipstick control is designed to validate visual & instrumental readings of urine dipsticks by immer more...
Nanogen Inc | Address: 10398 Pacific Center Ct, San Diego, California 92121, USA
www.nanogen.com | Phone: +1-(877)-626-6436
Year Established: 1993
Products: Myoglobin (FDA Code: DDR), Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Genetic Testing Equipment, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Nanogen Inc focuses on diagnostics provide researchers, healthcare professionals and patients. We offer instrumentation, reagents and test kits. We develop biomedical and healthcare market products. more...
www.nanogen.com | Phone: +1-(877)-626-6436
Year Established: 1993
Products: Myoglobin (FDA Code: DDR), Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Genetic Testing Equipment, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Nanogen Inc focuses on diagnostics provide researchers, healthcare professionals and patients. We offer instrumentation, reagents and test kits. We develop biomedical and healthcare market products. more...
Nexus Dx, Inc. | Address: 6759 Mesa Ridge Road, Suite 100, San Diego, California 92121, USA
Phone: +1-(858)-410-4600
FDA Registration: 3008117742
Products: Myoglobin (FDA Code: DDR), General Surgical Instruments, Common Surgical Instrument, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), CPK Isoenzymes Chromatographic Separation Test (FDA Code: JHT), ...
Nexus Dx, Inc. specializes in offering surgical and medical instruments. more...
Phone: +1-(858)-410-4600
FDA Registration: 3008117742
Products: Myoglobin (FDA Code: DDR), General Surgical Instruments, Common Surgical Instrument, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), CPK Isoenzymes Chromatographic Separation Test (FDA Code: JHT), ...
Nexus Dx, Inc. specializes in offering surgical and medical instruments. more...
Sponsored Links
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.
