Assayed and Unassayed Single (Specified) Analyte Controls 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...
Qualigen Inc. | Address: 2042 Corte Del Nogal, Carlsbad, California 92011, USA
www.qualigeninc.com | Send Inquiry | Phone: +1-(760)-918-9165, 877-709-2169
FDA Registration: 2032087
Products: Immunoassay Systems, Automated Immunoassay Systems, Automated Homogeneous Liposome Immunoassay Systems, Multiple Immunoassay Systems, Substrates For Immunoassay Systems, Sensitive Immunoassay Systems, ...
Qualigen, Inc. fabricates and markets the FastPack® System, which is a fully automated blood testing system. Our products include fastpack® IP system, TSH, Free T4, hcG, Total PSA, and Testo. more...
www.qualigeninc.com | Send Inquiry | Phone: +1-(760)-918-9165, 877-709-2169
FDA Registration: 2032087
Products: Immunoassay Systems, Automated Immunoassay Systems, Automated Homogeneous Liposome Immunoassay Systems, Multiple Immunoassay Systems, Substrates For Immunoassay Systems, Sensitive Immunoassay Systems, ...
Qualigen, Inc. fabricates and markets the FastPack® System, which is a fully automated blood testing system. Our products include fastpack® IP system, TSH, Free T4, hcG, Total PSA, and Testo. more...
Hycor Biomedical Inc. | Address: 7272 Chapman Avenue, Garden Grove, California 92841, USA
www.hycorbiomedical.com | Send Inquiry | Phone: +1-(714)-933-3000
FDA Registration: 2016473
Products: Anti-MPO ANCA, Anti-Gliadin (Ab), Controls, General Diagnostic Supplies, General Medical Supplies, General Diagnostics, ...
Hycor Biomedical Inc. manufactures diagnostic products and distributes to clinical laboratories. We offer products like allergy testing, autoimmune testing, urinalysis, infectious disease healthcare p more...
www.hycorbiomedical.com | Send Inquiry | Phone: +1-(714)-933-3000
FDA Registration: 2016473
Products: Anti-MPO ANCA, Anti-Gliadin (Ab), Controls, General Diagnostic Supplies, General Medical Supplies, General Diagnostics, ...
Hycor Biomedical Inc. manufactures diagnostic products and distributes to clinical laboratories. We offer products like allergy testing, autoimmune testing, urinalysis, infectious disease healthcare p 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: HIV Screening - Western Blot, Cytomegalovirus (CMV) Test Kits, General Medical Supplies, Blotting Equipment, Hepatitis C Test Kit, Autoimmune Test Kits, ...
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: HIV Screening - Western Blot, Cytomegalovirus (CMV) Test Kits, General Medical Supplies, Blotting Equipment, Hepatitis C Test Kit, Autoimmune Test Kits, ...
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...
Links Medical Products Inc. | Address: 9247 Research Drive, Irvine, California 92618, USA
www.linksmed.com | Send Inquiry | Phone: +1-(949)-753-0001,888-425-1149
FDA Registration: 2031987
Products: Blood Glucose Meters, General Surgery Supplies, Blood Glucose Monitoring Systems, Blood Glucose Kits, Blood Glucose Monitors, Graduated Liquid Medication Container (FDA Code: KYW), ...
Links Medical Products Inc. develops, manufactures and distributes products for use in both acute & long-term care. Our product list comprises of tablet crushing system, beverage thickener, blood gluc more...
www.linksmed.com | Send Inquiry | Phone: +1-(949)-753-0001,888-425-1149
FDA Registration: 2031987
Products: Blood Glucose Meters, General Surgery Supplies, Blood Glucose Monitoring Systems, Blood Glucose Kits, Blood Glucose Monitors, Graduated Liquid Medication Container (FDA Code: KYW), ...
Links Medical Products Inc. develops, manufactures and distributes products for use in both acute & long-term care. Our product list comprises of tablet crushing system, beverage thickener, blood gluc more...
Diazyme Laboratories | Address: 12889 Gregg Ct., Poway, California 92064, USA
www.diazyme-ga.com | Send Inquiry | Phone: +1-(858)-455-4768
FDA Registration: 2032900
Products: Gamma-GT, Amylase, Creatinine, Uric Acid, Lithium, Salivary Amylase, ...
Diazyme Laboratories develops uniform diagnostic products for clinical and research use. We are an ISO certified company. Our enzymatic tHcy assay is based on a novel assay principle that assesses the more...
www.diazyme-ga.com | Send Inquiry | Phone: +1-(858)-455-4768
FDA Registration: 2032900
Products: Gamma-GT, Amylase, Creatinine, Uric Acid, Lithium, Salivary Amylase, ...
Diazyme Laboratories develops uniform diagnostic products for clinical and research use. We are an ISO certified company. Our enzymatic tHcy assay is based on a novel assay principle that assesses the 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: Amines Test Kits, Chemistry Analyzers, Controls, Clinical Immunochemistry Analyzers, Early Pregnancy Testing Kit, Diagnostic Test Kits For Pregnancy, ...
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: Amines Test Kits, Chemistry Analyzers, Controls, Clinical Immunochemistry Analyzers, Early Pregnancy Testing Kit, Diagnostic Test Kits For Pregnancy, ...
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...
ACON Laboratories, Inc. | Address: 4108 Sorrento Valley Boulevard, San Diego, California 92121, USA
www.aconlab.com | Send Inquiry | Phone: +1-(858)-535-2030
FDA Registration: 2531491 Year Established: 1996 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001, CE Certified
Products: Helicobacter pylori Urease Test Kits, Menopause and Fertility Impairment (FSH) Test Kits, Ovulation (Luteinizing Hormone) Test Kits, Streptococcus Test Kits, Total Prostate-Specific Antigen (PSA), Swabs, Streptococcus Test Kits, ...
ACON Laboratories, Inc. provides a broad range of quality and competitively priced lateral flow rapid diagnostic tests. We are an ISO 9001, CE MARK certified company. We currently sell over 100 diagno more...
www.aconlab.com | Send Inquiry | Phone: +1-(858)-535-2030
FDA Registration: 2531491 Year Established: 1996 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001, CE Certified
Products: Helicobacter pylori Urease Test Kits, Menopause and Fertility Impairment (FSH) Test Kits, Ovulation (Luteinizing Hormone) Test Kits, Streptococcus Test Kits, Total Prostate-Specific Antigen (PSA), Swabs, Streptococcus Test Kits, ...
ACON Laboratories, Inc. provides a broad range of quality and competitively priced lateral flow rapid diagnostic tests. We are an ISO 9001, CE MARK certified company. We currently sell over 100 diagno more...
Biosite Incorporated | Address: 11030 Roselle Street, San Diego, California 92121, USA
www.biosite.com | Phone: +1-(858)-455-4808
FDA Registration: 2027969
Products: B-Type Natriuretic Peptide (BNP), Clostridium difficile Test Kits, POC Cardiac Marker Analyzers, Microbiology Kit, General Diagnostic Supplies, Drugs Of Abuse Test Kits, ...
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: B-Type Natriuretic Peptide (BNP), Clostridium difficile Test Kits, POC Cardiac Marker Analyzers, Microbiology Kit, General Diagnostic Supplies, Drugs Of Abuse Test Kits, ...
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...
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, Immunochemistry Analyzers, C-Reactive Protein (CRP), Troponin I, Plasma Protein 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, Immunochemistry Analyzers, C-Reactive Protein (CRP), Troponin I, Plasma Protein 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...
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: Pregnancy Kits, Cotton Swabs, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Sensitive Pregnancy Tests, Diagnostic Test Kits For Pregnancy, ...
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: Pregnancy Kits, Cotton Swabs, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Sensitive Pregnancy Tests, Diagnostic Test Kits For Pregnancy, ...
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: Albumin, Albumin Reagent Set, Acid, Hydroxyazobenzene-Benzoic, Albumin (FDA Code: CJZ), Acetylcholine Chloride Reagent (FDA Code: DLI), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO), 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL), ...
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: Albumin, Albumin Reagent Set, Acid, Hydroxyazobenzene-Benzoic, Albumin (FDA Code: CJZ), Acetylcholine Chloride Reagent (FDA Code: DLI), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO), 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL), ...
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...
PerkinElmer, Inc.(LAS) | Address: 549 Albany Street, Boston, Massachusetts 02118-2512, USA
las.perkinelmer.com | Send Inquiry | Phone: +1-(203)-925-4602
Employee Count: ~9100
Products: Insulin, Insulin Growth Factor 1 Testing kit, Insulin Growth Factor and Binding Proteins III, Insulin Radioimmunoassay, Human Insulin ELISA Kit, Sensitive Rat Insulin RIA Kit, ...
PerkinElmer, Inc., manufactures and provides services for drug discovery, genetic screening and chemical analysis instrumentation, reagents and services for scientific research and clinical applicatio more...
las.perkinelmer.com | Send Inquiry | Phone: +1-(203)-925-4602
Employee Count: ~9100
Products: Insulin, Insulin Growth Factor 1 Testing kit, Insulin Growth Factor and Binding Proteins III, Insulin Radioimmunoassay, Human Insulin ELISA Kit, Sensitive Rat Insulin RIA Kit, ...
PerkinElmer, Inc., manufactures and provides services for drug discovery, genetic screening and chemical analysis instrumentation, reagents and services for scientific research and clinical applicatio 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: Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, Alternative Arthritis Treatments, ...
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: Hernia Repair Grafts, Arthritis Treatments, Miscellaneous Injectables, Vitamins & Minerals (Pediatric/Adult), Surgical Mesh, Hernia Repair Grafts, Alternative Arthritis Treatments, ...
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...
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, Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Electrolyte Chemistry Analyzer, Toxicology Lithium Flame Photometer, Automated Coagulation Timer, ...
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, Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Electrolyte Chemistry Analyzer, Toxicology Lithium Flame Photometer, Automated Coagulation Timer, ...
Instrumentation Laboratory (IL) manufactures and supplies critical care diagnostic & hemostasis instruments. We offer products like haemostatisis diagnostics, critical care diagnostics & acc trak. In 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: Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Pregnancy Test Kit, Human Chorionic Gonadotropin Test, Fertility Monitoring Test, ...
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: Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Pregnancy Test Kit, Human Chorionic Gonadotropin Test, Fertility Monitoring Test, ...
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...
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, Blood glucose testing, ...
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, Blood glucose testing, ...
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...
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: Hemoglobin A1C (Glycohemoglobin), Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin), Cholesterol Colorimetric Test (FDA Code: CGO), Lactate Dehydrogenase NAD Reduction/NADH Oxidation (FDA Code: CFJ), Urea Nitrogen Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ), Glycosylated Hemoglobin Assay Test (FDA Code: LCP), ...
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: Hemoglobin A1C (Glycohemoglobin), Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin), Cholesterol Colorimetric Test (FDA Code: CGO), Lactate Dehydrogenase NAD Reduction/NADH Oxidation (FDA Code: CFJ), Urea Nitrogen Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ), Glycosylated Hemoglobin Assay Test (FDA Code: LCP), ...
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...
International Technidyne Corp. | Address: 8 Olsen Ave, Edison, New Jersey 08820, USA
www.itcmed.com | Send Inquiry | Phone: +1-(732)-548-6677
Annual Revenues: USD 25-50 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Blood Gas Analyzers, Hemoglobin Testing Systems, Hemoglobin Analyzers, POC Coagulation Analyzers (PT and INR), Blood, Hemoglobin Analyzers, Oximeters, ...
International Technidyne Corp. specializes in the fields of hemostasis management and point-of-care testing. Our products include Hemochron® whole blood coagulation system, Tenderfoot®heel inc more...
www.itcmed.com | Send Inquiry | Phone: +1-(732)-548-6677
Annual Revenues: USD 25-50 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Blood Gas Analyzers, Hemoglobin Testing Systems, Hemoglobin Analyzers, POC Coagulation Analyzers (PT and INR), Blood, Hemoglobin Analyzers, Oximeters, ...
International Technidyne Corp. specializes in the fields of hemostasis management and point-of-care testing. Our products include Hemochron® whole blood coagulation system, Tenderfoot®heel inc more...
DRG International, Inc. | Address: 1167 US Highway 22 East, Mountainside, New Jersey 07092, USA
www.drg-international.com | Send Inquiry | Phone: +1-(908)-233-2075
FDA Registration: 2245285 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, CE Certified
Products: ANA (Antinuclear antibodies), Alpha Fetoprotein (AFP), Adrenocorticotropic Hormone, Alpha Fetoprotein Test Kit, Anti-Aldosterone, Enzyme Immunoassay (EIA) Kits, ...
DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoas more...
www.drg-international.com | Send Inquiry | Phone: +1-(908)-233-2075
FDA Registration: 2245285 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, CE Certified
Products: ANA (Antinuclear antibodies), Alpha Fetoprotein (AFP), Adrenocorticotropic Hormone, Alpha Fetoprotein Test Kit, Anti-Aldosterone, Enzyme Immunoassay (EIA) Kits, ...
DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoas 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.
