Urinalysis 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...
Iris Diagnostics | Address: 9172 Eton Avenue, Chatsworth, California 91311, USA
www.irisdiagnostics.com | Send Inquiry | Phone: +1-(818)-709-1244
FDA Registration: 2023446 Year Established: 1979 Annual Revenues: USD 50-100 Million Employee Count: ~90 Quality: CE Certified
Products: Micro Surgery Instruments, Micro Surgery Instruments, Pneumatic Power Systems, Micro Surgery Instruments, Graspers, Micro Surgery Instruments, Scissors, Automated Urinalysis System (FDA Code: KQO), Automated Urine Microscopy Analyzer, ...
Iris Diagnostics specializes in automated urinalysis technology. We produce clinical analyzers, which use real-time video flow imaging, displaying microscopic images on a video screen. Our systems are more...
www.irisdiagnostics.com | Send Inquiry | Phone: +1-(818)-709-1244
FDA Registration: 2023446 Year Established: 1979 Annual Revenues: USD 50-100 Million Employee Count: ~90 Quality: CE Certified
Products: Micro Surgery Instruments, Micro Surgery Instruments, Pneumatic Power Systems, Micro Surgery Instruments, Graspers, Micro Surgery Instruments, Scissors, Automated Urinalysis System (FDA Code: KQO), Automated Urine Microscopy Analyzer, ...
Iris Diagnostics specializes in automated urinalysis technology. We produce clinical analyzers, which use real-time video flow imaging, displaying microscopic images on a video screen. Our systems are 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...
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...
Sysmex America, Inc. | Address: One Nelson C. White Parkway, Mundelein, Illinois 60060, USA
www.sysmex.com | Send Inquiry | Phone: +1-(847)-996-4500, 800-379-7639
FDA Registration: 1422681
Products: Controls, General Diagnostic Supplies, General Diagnostics, Blood, Hematology Analyzers, Automated Hematology Analyzers, Flow Particle Image Analyzer, ...
Sysmex America, Inc. manufactures and markets clinical laboratory testing devices, reagents, and software for hematology, hemostasis, immuno-chemistry, particle counting and urinalysis and also distri more...
www.sysmex.com | Send Inquiry | Phone: +1-(847)-996-4500, 800-379-7639
FDA Registration: 1422681
Products: Controls, General Diagnostic Supplies, General Diagnostics, Blood, Hematology Analyzers, Automated Hematology Analyzers, Flow Particle Image Analyzer, ...
Sysmex America, Inc. manufactures and markets clinical laboratory testing devices, reagents, and software for hematology, hemostasis, immuno-chemistry, particle counting and urinalysis and also distri 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...
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...
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...
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: Slide Staining, General Medical Supplies, General Examination Supplies, Manual Slide Staining System, Microscope Slide Staining Kit, EasyDip Slide Staining, ...
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: Slide Staining, General Medical Supplies, General Examination Supplies, Manual Slide Staining System, Microscope Slide Staining Kit, EasyDip Slide Staining, ...
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...
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, Ferritin Testing Kit, Gamma Dab Ferritin Kit, RIA Gnost Ferritin Kit, Ferritin Enzyme Immunoassay Test 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, Ferritin Testing Kit, Gamma Dab Ferritin Kit, RIA Gnost Ferritin Kit, Ferritin Enzyme Immunoassay Test 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...
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: Lyme Disease (Borrelia) Test Kits, Infectious Disease Test Kits, Lyme Disease Test, Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL), Streptococcus Spp Antiserum (FDA Code: GTZ), Mounting Media (FDA Code: LEB), ...
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: Lyme Disease (Borrelia) Test Kits, Infectious Disease Test Kits, Lyme Disease Test, Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL), Streptococcus Spp Antiserum (FDA Code: GTZ), Mounting Media (FDA Code: LEB), ...
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...
Myers-Stevens & Toohey & Co., Inc. | Address: 2931 Vail Ave, Commerce, California 90040, USA
www.myers-stevens.com | Send Inquiry | Phone: +1-(800)-827-4695
FDA Registration: 2025932
Products: Personal Life Insurance Programs, Insurance, Insurance Service, Property & Casualty Insurance Service, Insurance Providers, Insurance & Risk Management, ...
Myers-Stevens & Toohey & Co., Inc. offers a variety of individual and group health insurance plans. We administer long term disability, life, long term care, accidental death, and accident medical ins more...
www.myers-stevens.com | Send Inquiry | Phone: +1-(800)-827-4695
FDA Registration: 2025932
Products: Personal Life Insurance Programs, Insurance, Insurance Service, Property & Casualty Insurance Service, Insurance Providers, Insurance & Risk Management, ...
Myers-Stevens & Toohey & Co., Inc. offers a variety of individual and group health insurance plans. We administer long term disability, life, long term care, accidental death, and accident medical ins 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-HbsAg IgG, Monoclonal Antibody Test, Polyclonal Antibody, ...
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-HbsAg IgG, Monoclonal Antibody Test, Polyclonal Antibody, ...
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...
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: Blood Collect Tubes, Controls for Diagnostic Equipment, Diabetic Monitoring, General Diagnostic Supplies, General Medical Supplies, General Examination Supplies, ...
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: Blood Collect Tubes, Controls for Diagnostic Equipment, Diabetic Monitoring, General Diagnostic Supplies, General Medical Supplies, General Examination Supplies, ...
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...
Kenlor Industries, Inc. | Address: 1560 East Edinger Ave., Suite A-1, Santa Ana, California 92705, USA
www.kenlor.com | Send Inquiry | Phone: +1-(714)-647-0770, 800-899-9371
FDA Registration: 2027370
Products: Urinalysis Controls (FDA Code: JJW), Total Spinal Fluid Control (FDA Code: DFI), Campylobacter Pylori (FDA Code: LYR), ...
Kenlor Industries, Inc. specializes in liquid control products. We offer liquid urine control for dipstick & microscopic analysis, liquid urine control for quantitative assay, liquid human spinal flui more...
www.kenlor.com | Send Inquiry | Phone: +1-(714)-647-0770, 800-899-9371
FDA Registration: 2027370
Products: Urinalysis Controls (FDA Code: JJW), Total Spinal Fluid Control (FDA Code: DFI), Campylobacter Pylori (FDA Code: LYR), ...
Kenlor Industries, Inc. specializes in liquid control products. We offer liquid urine control for dipstick & microscopic analysis, liquid urine control for quantitative assay, liquid human spinal flui more...
Diagnostic Test Group, Llc | Address: 141 N.W. 20th St., Suite H-3, Boca Raton, Florida 33431, USA
www.claritydiagnostics.com | Send Inquiry | Phone: +1-(561)-347-5760
FDA Registration: 3004043187
Products: Glucose Test Kits, Fecal Occult Blood Test, Hcg Pregnancy Test Strip, General Urinalysis Devices, HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX), Urinalysis Controls (FDA Code: JJW), ...
Diagnostic Test Group, LLC is a manufacturer and distributor of laboratory diagnostic products. We offer clarity urinalysis, clarity strep tests, clarity pregnancy (hCG) tests, fecal occult tests, cho more...
www.claritydiagnostics.com | Send Inquiry | Phone: +1-(561)-347-5760
FDA Registration: 3004043187
Products: Glucose Test Kits, Fecal Occult Blood Test, Hcg Pregnancy Test Strip, General Urinalysis Devices, HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX), Urinalysis Controls (FDA Code: JJW), ...
Diagnostic Test Group, LLC is a manufacturer and distributor of laboratory diagnostic products. We offer clarity urinalysis, clarity strep tests, clarity pregnancy (hCG) tests, fecal occult tests, cho more...
Health Chem Diagnostics LLC | Address: 3341 S.W. 15th St., Pompano Beach, Florida 33069-4808, USA
www.healthchemdiagnostics.com | Send Inquiry | Phone: +1-(954)-979-3845
FDA Registration: 1048532
Products: Fertility Monitors, Pregnancy Test Kits, Alpha-Fetoprotein Rapid Test Strip, Fecal Occult Blood Test Strip, BreathScanr Alcohol Detector, Prostate Specific Antigen Test (FDA Code: MTG), Urine Teststrips, ...
Health Chem Diagnostics LLC manufactures point-of-care medical diagnostic products for use at home, in physician office, and in other healthcare locations & markets. Our products are alcohol testing, more...
www.healthchemdiagnostics.com | Send Inquiry | Phone: +1-(954)-979-3845
FDA Registration: 1048532
Products: Fertility Monitors, Pregnancy Test Kits, Alpha-Fetoprotein Rapid Test Strip, Fecal Occult Blood Test Strip, BreathScanr Alcohol Detector, Prostate Specific Antigen Test (FDA Code: MTG), Urine Teststrips, ...
Health Chem Diagnostics LLC manufactures point-of-care medical diagnostic products for use at home, in physician office, and in other healthcare locations & markets. Our products are alcohol testing, more...
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FDA Code / Regulation: JJW / 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.
