Carcinoembryonic Antigen Test System Suppliers
Limit companies to: Worldwide USA
Biocheck, Inc. | Address: 323 Vintage Park Dr., Foster City, California 94404, USA 
www.biocheckinc.com | Send Inquiry | Phone: +1-(650)-573-1968
FDA Registration: 2953756 Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: Testosterone, Estradiol, Luteinizing Hormone (LH), Prolactin Kit, Ferritin (FDA Code: DBF), Human Chorionic Gonadotropin (hCG), ...
Biocheck, Inc. develops and distributes immunodiagnostic test kits for the healthcare markets. We are an ISO 9001, CE certified company. We offer products such as tumor markers, thyroid, steroids, car more...
www.biocheckinc.com | Send Inquiry | Phone: +1-(650)-573-1968
FDA Registration: 2953756 Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: Testosterone, Estradiol, Luteinizing Hormone (LH), Prolactin Kit, Ferritin (FDA Code: DBF), Human Chorionic Gonadotropin (hCG), ...
Biocheck, Inc. develops and distributes immunodiagnostic test kits for the healthcare markets. We are an ISO 9001, CE certified company. We offer products such as tumor markers, thyroid, steroids, car more...
Siemens Healthcare Diagnostics | Address: 1717 Deerfield Road, Deerfield, Illinois 60015-0778, USA
www.usa.siemens.com/diagnostics | Phone: +1-(847)-267-5300
Quality: ISO 9000, CE Certified
Products: Laboratory Automation Systems, Biochemistry Analyzers, Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Immunoassay Systems, Immunochemistry Analyzers, ...
Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehen more...
www.usa.siemens.com/diagnostics | Phone: +1-(847)-267-5300
Quality: ISO 9000, CE Certified
Products: Laboratory Automation Systems, Biochemistry Analyzers, Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Immunoassay Systems, Immunochemistry Analyzers, ...
Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehen more...
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...
Ameritek U.S.A. | Address: 125 130th St. SE, Suite #200, Everett, Washington 98208, USA
www.ameritek.org | Send Inquiry | Phone: +1-(425))-379-2580
FDA Registration: 3025672
Products: Myoglobin (FDA Code: DDR), Ovulation (Luteinizing Hormone) Test Kits, Ferritin (FDA Code: DBF), Foreign Body Retrieval Magnets, Ophthalmic Surgery Instruments, Foreign Body Retrieval Magnets, Femlab Vaginitis Cassette, ...
Ameritek U.S.A. specializes in rapid in-vitro immunodiagnostic and clinical reagent tests. We deliver various packaging options for our products. We offer white OEM packaging, our best brand & customi more...
www.ameritek.org | Send Inquiry | Phone: +1-(425))-379-2580
FDA Registration: 3025672
Products: Myoglobin (FDA Code: DDR), Ovulation (Luteinizing Hormone) Test Kits, Ferritin (FDA Code: DBF), Foreign Body Retrieval Magnets, Ophthalmic Surgery Instruments, Foreign Body Retrieval Magnets, Femlab Vaginitis Cassette, ...
Ameritek U.S.A. specializes in rapid in-vitro immunodiagnostic and clinical reagent tests. We deliver various packaging options for our products. We offer white OEM packaging, our best brand & customi 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...
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...
Monobind Inc. | Address: 100 N Point Drive, Lake Forrest, California 92630, USA
www.monobind.com | Send Inquiry | Phone: +1-(949)-951-2665, 800-854-6265
FDA Registration: 2020726 Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Calibrators, Hcg Test kits, Cancer Marker Assays, Infectious Diseases Assays, Immunoassays, Cardiac Markers, ...
Monobind Inc. offers laboratory diagnostic products. Our product categories are immunoassays, R&D immunoassay tools, instruments and biomaterials. Our product list comprises of streptavidin coated pla more...
www.monobind.com | Send Inquiry | Phone: +1-(949)-951-2665, 800-854-6265
FDA Registration: 2020726 Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Calibrators, Hcg Test kits, Cancer Marker Assays, Infectious Diseases Assays, Immunoassays, Cardiac Markers, ...
Monobind Inc. offers laboratory diagnostic products. Our product categories are immunoassays, R&D immunoassay tools, instruments and biomaterials. Our product list comprises of streptavidin coated pla more...
Innovacon, Inc. | Address: 9975 Summers Ridge Road, San Diego, California 92121, USA
www.innovaconinc.com | Send Inquiry | Phone: +1-(858)-805-8900
Products: Luteinizing Hormone (LH), Fecal Occult Blood Test Kits, Chlamydia Test Kits, Rotavirus Test Kits, Carcinoembryonic antigen (CEA), Hepatitis C Antibody Test Kits, ...
Innovacon, Inc., a subsidiary of Inverness Medical Innovations, develops and markets a wide range of professional & consumer medical diagnostic products. Our product categories are drugs of abuse, wom more...
www.innovaconinc.com | Send Inquiry | Phone: +1-(858)-805-8900
Products: Luteinizing Hormone (LH), Fecal Occult Blood Test Kits, Chlamydia Test Kits, Rotavirus Test Kits, Carcinoembryonic antigen (CEA), Hepatitis C Antibody Test Kits, ...
Innovacon, Inc., a subsidiary of Inverness Medical Innovations, develops and markets a wide range of professional & consumer medical diagnostic products. Our product categories are drugs of abuse, wom more...
UCP Biosciences, Inc. | Address: 1445 Koll Circle, Ste. 111, San Jose, California 95112, USA
www.ucpbiosciences.com | Send Inquiry | Phone: +1-(408)-392-0064
FDA Registration: 3004987297
Products: Tumor Markers, H. Pylori Test Kits, H.Pylori Testing kits, HIV and H.Pylori testing kits, Hcg Pregnancy Test Strip, Menopause Test kits, ...
UCP Biosciences, Inc. specializes in lateral flow rapid tests by utilizing thin-layer chromatography to detect the presence of specific antigens, antibodies in urine, feces, serum, plasma or whole blo more...
www.ucpbiosciences.com | Send Inquiry | Phone: +1-(408)-392-0064
FDA Registration: 3004987297
Products: Tumor Markers, H. Pylori Test Kits, H.Pylori Testing kits, HIV and H.Pylori testing kits, Hcg Pregnancy Test Strip, Menopause Test kits, ...
UCP Biosciences, Inc. specializes in lateral flow rapid tests by utilizing thin-layer chromatography to detect the presence of specific antigens, antibodies in urine, feces, serum, plasma or whole blo more...
Abbott Hematology | Address: 5440 Patrick Henry Dr., Santa Clara, California 95054, USA
www.abbott.us | Phone: +1-(408)-982-4800
FDA Registration: 2919069 Employee Count: ~72000 Quality: ISO 9001, CE Certified
Products: Myoglobin (FDA Code: DDR), Catheter Introducers (FDA Code: DYB), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Carotid Stent Systems (FDA Code: NIM), Diagnostic Instruments, ...
Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a more...
www.abbott.us | Phone: +1-(408)-982-4800
FDA Registration: 2919069 Employee Count: ~72000 Quality: ISO 9001, CE Certified
Products: Myoglobin (FDA Code: DDR), Catheter Introducers (FDA Code: DYB), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Carotid Stent Systems (FDA Code: NIM), Diagnostic Instruments, ...
Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a more...
Carclo Technical Plastics | Address: 6009 Enterprise Drive, Export, Pennsylvania 15632, USA
Phone: +1-(724)-539-1833
FDA Registration: 2530112
Products: Myoglobin (FDA Code: DDR), Continuous Ventilator (FDA Code: CBK), Non-Continuous Ventilator/Respirator (FDA Code: BZD), Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), ACTH Radioimmunoassay Test (FDA Code: CKG), C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD), ...
Carclo Technical Plastics is associated with immunoassay tests. more...
Phone: +1-(724)-539-1833
FDA Registration: 2530112
Products: Myoglobin (FDA Code: DDR), Continuous Ventilator (FDA Code: CBK), Non-Continuous Ventilator/Respirator (FDA Code: BZD), Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), ACTH Radioimmunoassay Test (FDA Code: CKG), C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD), ...
Carclo Technical Plastics is associated with immunoassay tests. more...
Applicare Medical Imaging, B.V. | Address: Sparrenheuvel 38, Zeist, JE 3708, Netherlands
Products: Blood pressure Cuffs (FDA Code: DXQ), Oximeters (FDA Code: DQA), Bone Densitometer (FDA Code: KGI), Reservoir Bag (FDA Code: BTC), Neonatal Incubators (FDA Code: FMZ), Electroencephalographs (FDA Code: GWQ), ...
Applicare Medical Imaging, B.V. provides medical imaging, teleradiology and PACS solutions. more...
Products: Blood pressure Cuffs (FDA Code: DXQ), Oximeters (FDA Code: DQA), Bone Densitometer (FDA Code: KGI), Reservoir Bag (FDA Code: BTC), Neonatal Incubators (FDA Code: FMZ), Electroencephalographs (FDA Code: GWQ), ...
Applicare Medical Imaging, B.V. provides medical imaging, teleradiology and PACS solutions. more...
Laboratorio De Analisis Clinicos Plaza | Address: Circuito Centro Comercial 37-4topiso, Ciudad Satelite, Naucalpan De Juarez, MEX 53100, Mexico
Phone: 5/512-6345
Annual Revenues: < USD 1 Million
Products: Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Centrifugal Chemistry Analyzer (FDA Code: JJG), Electrolyte Chemistry Analyzer, Programmable Multi-Channel Chemistry Analyzer, Therapeutic Drug Monitor Chemistry Analyzer, ...
Laboratorio De Analisis Clinicos Plaza offers CO-oximeter, electrolyte chemistry analyzer and automated coagulation analyzer. more...
Phone: 5/512-6345
Annual Revenues: < USD 1 Million
Products: Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Centrifugal Chemistry Analyzer (FDA Code: JJG), Electrolyte Chemistry Analyzer, Programmable Multi-Channel Chemistry Analyzer, Therapeutic Drug Monitor Chemistry Analyzer, ...
Laboratorio De Analisis Clinicos Plaza offers CO-oximeter, electrolyte chemistry analyzer and automated coagulation analyzer. more...
Dainabot Co., Ltd. | Address: 4, Rotsupongi First Bldg, 9-9, Roppongi 1-chome, Minato-Ku, Tokyo 106-0032, Japan
Phone: +81-(3)-35899591
Products: Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP), Carcinoembryonic Antigen Test System (FDA Code: DHX), ...
Dainabot Co., Ltd. offers various insulin assays and immunoassay apparatus. more...
Phone: +81-(3)-35899591
Products: Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP), Carcinoembryonic Antigen Test System (FDA Code: DHX), ...
Dainabot Co., Ltd. offers various insulin assays and immunoassay apparatus. more...
Tosoh Corp. | Address: 3-8-2 Shiba, Minato-Ku, Tokyo, Japan
www.tosoh.com | Send Inquiry | Phone: +81-(3)-5427-5118
FDA Registration: 8031673 Year Established: 1935
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD), ...
Tosoh Corp. is a supplier of chromatographic columns, media and diagnostic systems. Our product list comprises of fully automated random access enzyme immunoassay systems, reagent systems, fully autom more...
www.tosoh.com | Send Inquiry | Phone: +81-(3)-5427-5118
FDA Registration: 8031673 Year Established: 1935
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD), ...
Tosoh Corp. is a supplier of chromatographic columns, media and diagnostic systems. Our product list comprises of fully automated random access enzyme immunoassay systems, reagent systems, fully autom more...
Biomerieux Italy | Address: Via Di Campigliano 58, Bagno a Ripoli (Florence) 50012, Italy
www.biomerieux.it | Phone: +39-(55)-64497
FDA Registration: 9615037
Products: Ferritin (FDA Code: DBF), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Quality Control Kits (FDA Code: JTR), Cytocentrifuge (FDA Code: IFB), Pasteur Pipettes (FDA Code: GJW), ...
Biomerieux Italy specializes in developing, manufacturing and marketing of instruments & reagents for clinical and microbiological monitoring in pharmaceuticals. We provide a range of diagnostic solut more...
www.biomerieux.it | Phone: +39-(55)-64497
FDA Registration: 9615037
Products: Ferritin (FDA Code: DBF), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Quality Control Kits (FDA Code: JTR), Cytocentrifuge (FDA Code: IFB), Pasteur Pipettes (FDA Code: GJW), ...
Biomerieux Italy specializes in developing, manufacturing and marketing of instruments & reagents for clinical and microbiological monitoring in pharmaceuticals. We provide a range of diagnostic solut more...
Instrumentation Laboratory SpA | Address: V.le Monza 338, Milan, Italy
www.il-italia.it | Phone: +39-(02)-25221
Annual Revenues: USD 1-5 Million Employee Count: ~490
Products: Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Angiographic Catheter, El Gamal Sones, Angiographic Catheter, El Gamal Multipurpose, ...
Instrumentation Laboratory SpA specializes in clinical and in vitro diagnostic instruments for critical care & hemostasis. We offer systems for blood gas, electrolytes, hemostasis-coagulation and clin more...
www.il-italia.it | Phone: +39-(02)-25221
Annual Revenues: USD 1-5 Million Employee Count: ~490
Products: Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Angiographic Catheter, El Gamal Sones, Angiographic Catheter, El Gamal Multipurpose, ...
Instrumentation Laboratory SpA specializes in clinical and in vitro diagnostic instruments for critical care & hemostasis. We offer systems for blood gas, electrolytes, hemostasis-coagulation and clin more...
Olympus Life Science Research Europa Gmbh (Europa) | Address: Lismeehan, O'Callaghans Mills, Co. Clare, Ireland
Send Inquiry | Phone: +353-(65)-6831100
FDA Registration: 9680746
Products: Alkaline Phosphatase (ALP) (FDA Code: JCJ), Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Isotonic Solution (FDA Code: JCE), Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), ...
Olympus Life Science Research Europa Gmbh (Europa) manufactures microscope systems for life and material science, high-performance analytical systems and reagents for clinical laboratories. Our diagno more...
Send Inquiry | Phone: +353-(65)-6831100
FDA Registration: 9680746
Products: Alkaline Phosphatase (ALP) (FDA Code: JCJ), Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Isotonic Solution (FDA Code: JCE), Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB), Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE), ...
Olympus Life Science Research Europa Gmbh (Europa) manufactures microscope systems for life and material science, high-performance analytical systems and reagents for clinical laboratories. Our diagno more...
Roche Diagnostics Gmbh | Address: Sandhoferstrasse 116, Mannheim D-68298, Germany 
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Urinalysis System (FDA Code: KQO), Nephelometer (FDA Code: JZW), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products more...
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Capillary Blood Collection Tubes (FDA Code: GIO), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Urinalysis System (FDA Code: KQO), Nephelometer (FDA Code: JZW), ...
Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products more...
Instrumentation Laboratory S.A. | Address: 32 Avenue De Saint Mande B p 35, Paris Cedex 12 75560, France
www.instrumentationlaboratory.com | Phone: +33-(1)-43-46-11-44
Employee Count: ~60 Quality: ISO 9002, CE Certified
Products: Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Centrifugal Chemistry Analyzer (FDA Code: JJG), Electrolyte Chemistry Analyzer, Programmable Multi-Channel Chemistry Analyzer, Carbamazepine Enzyme Immunoassay Test (FDA Code: KLT), ...
Instrumentation Laboratory S.A. specializes in offering diagnostic instruments for critical care and hemostasis. We provide centrifugal analyzer, enhanced solid state fluidics and CO-oximetry. We also more...
www.instrumentationlaboratory.com | Phone: +33-(1)-43-46-11-44
Employee Count: ~60 Quality: ISO 9002, CE Certified
Products: Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Centrifugal Chemistry Analyzer (FDA Code: JJG), Electrolyte Chemistry Analyzer, Programmable Multi-Channel Chemistry Analyzer, Carbamazepine Enzyme Immunoassay Test (FDA Code: KLT), ...
Instrumentation Laboratory S.A. specializes in offering diagnostic instruments for critical care and hemostasis. We provide centrifugal analyzer, enhanced solid state fluidics and CO-oximetry. We also more...
Sponsored Links
FDA Code / Regulation: DHX / 866.6010
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
