Prostate-Specific Antigen for Management of Prostate Cancers Suppliers
Limit companies to: Worldwide USA
Diagnostic Automation, Inc. | Address: 23961 Craftsman Rd. Suite E/F, Calabasas, California 91302-2521, USA 
www.rapidtest.com/index2.htm | Send Inquiry | Phone: +1-(818)-591-3030
Products: Anti-MPO ANCA, Intact PTH, Troponin I, Myoglobin (FDA Code: DDR), Testosterone, Estradiol, ...
Diagnostic Automation, Inc. is a manufacturer and distributor of one step rapid tests & Elisa kits. We also offer IFA kits, chemiluminescence kits, serology tests and instruments. Chemiluminescence im more...
www.rapidtest.com/index2.htm | Send Inquiry | Phone: +1-(818)-591-3030
Products: Anti-MPO ANCA, Intact PTH, Troponin I, Myoglobin (FDA Code: DDR), Testosterone, Estradiol, ...
Diagnostic Automation, Inc. is a manufacturer and distributor of one step rapid tests & Elisa kits. We also offer IFA kits, chemiluminescence kits, serology tests and instruments. Chemiluminescence im 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, Prostate Specific Antigen Testing kit, Human Chorionic Gonadotropin (hCG) Enzyme Immunoassay Test Kit, Automated Immunoassay Systems, Automated Homogeneous Liposome Immunoassay Systems, Multiple 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, Prostate Specific Antigen Testing kit, Human Chorionic Gonadotropin (hCG) Enzyme Immunoassay Test Kit, Automated Immunoassay Systems, Automated Homogeneous Liposome Immunoassay Systems, Multiple 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...
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...
Biomerica | Address: 1533 Monrovia Avenue, Newport Beach, California 92663, USA
www.biomerica.com | Send Inquiry | Phone: +1-(949)-645-2111
FDA Registration: 2025099 Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO, CE Certified
Products: Calcitonin, Intact PTH, Erythropoietin (Epo), Human Chorionic Gonadotropin (hCG), Total Prostate-Specific Antigen (PSA), Insulin Autoantibody (IAA), ...
Biomerica manufactures and distributes medical diagnostic products for the laboratory, doctor's office & pharmacy use. Our products are used for the detection & monitoring of chronic diseases & certai more...
www.biomerica.com | Send Inquiry | Phone: +1-(949)-645-2111
FDA Registration: 2025099 Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO, CE Certified
Products: Calcitonin, Intact PTH, Erythropoietin (Epo), Human Chorionic Gonadotropin (hCG), Total Prostate-Specific Antigen (PSA), Insulin Autoantibody (IAA), ...
Biomerica manufactures and distributes medical diagnostic products for the laboratory, doctor's office & pharmacy use. Our products are used for the detection & monitoring of chronic diseases & certai more...
Alfa Scientific Designs, Inc. | Address: 13200 Gregg Street, Poway, California 92064, USA
www.alfascientific.com | Send Inquiry | Phone: +1-(858)-513-3888
FDA Registration: 2060833 Year Established: 1996 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Ovulation (Luteinizing Hormone) Test Kits, General Diagnostic Supplies, Drug Testing Kits, Drugs Of Abuse Test Kits, Drug Testing System, Cancer Marker Tests, ...
Alfa Scientific Designs, Inc. develops & manufactures quality rapid in-vitro diagnostic devices to serve the point-of-care marketplace including hospitals, physicians, criminal justice & occupational more...
www.alfascientific.com | Send Inquiry | Phone: +1-(858)-513-3888
FDA Registration: 2060833 Year Established: 1996 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Ovulation (Luteinizing Hormone) Test Kits, General Diagnostic Supplies, Drug Testing Kits, Drugs Of Abuse Test Kits, Drug Testing System, Cancer Marker Tests, ...
Alfa Scientific Designs, Inc. develops & manufactures quality rapid in-vitro diagnostic devices to serve the point-of-care marketplace including hospitals, physicians, criminal justice & occupational 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...
Akers Biosciences, Inc. | Address: 201 Grove Road, Thorofare, New Jersey 08086, USA
www.akersbiosciences.com | Send Inquiry | Phone: +1-(856)-848-8698
FDA Registration: 2247413 Year Established: 1989 Annual Revenues: USD 10-25 Million Employee Count: ~40
Products: Creatinine Test Strips, Rheumatoid Factor (RF), Blood Glucose Test Strips, Hcg Pregnancy Test Strip, Urine Ketone Test Strip, Mouse Rheumatoid Factor (RF) ELISA Kit, ...
Akers Biosciences, Inc. provides two rapid manual assays into the clinical laboratory, which include Pifa® Heparin/PF4 rapid assay and the lithium system. We offer products such as breathscanr, PI more...
www.akersbiosciences.com | Send Inquiry | Phone: +1-(856)-848-8698
FDA Registration: 2247413 Year Established: 1989 Annual Revenues: USD 10-25 Million Employee Count: ~40
Products: Creatinine Test Strips, Rheumatoid Factor (RF), Blood Glucose Test Strips, Hcg Pregnancy Test Strip, Urine Ketone Test Strip, Mouse Rheumatoid Factor (RF) ELISA Kit, ...
Akers Biosciences, Inc. provides two rapid manual assays into the clinical laboratory, which include Pifa® Heparin/PF4 rapid assay and the lithium system. We offer products such as breathscanr, PI 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...
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...
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...
Lumiquick Diagnostics, Inc. | Address: 2946 Scott Blvd., Santa Clara, California 95054, USA
www.lumiquick.com | Send Inquiry | Phone: +1-(408)-8550061
FDA Registration: 3005984081 Quality: ISO 13485:2003 Certified
Products: Influenza A, B Test Kits, Fecal Occult Blood Test Kits, Fecal Occult Blood Test, Hepatitis Disease Surface Antigen (HBsAg) Test Kits, Myoglobin Ria Test Kit, Cardiac Markers kits, ...
Lumiquick Diagnostics, Inc. is engaged in the manufacture of care immunoassay kits. Our products include rapid test kits, ELISA and latex tests kits & raw materials. These products provide the immunoa more...
www.lumiquick.com | Send Inquiry | Phone: +1-(408)-8550061
FDA Registration: 3005984081 Quality: ISO 13485:2003 Certified
Products: Influenza A, B Test Kits, Fecal Occult Blood Test Kits, Fecal Occult Blood Test, Hepatitis Disease Surface Antigen (HBsAg) Test Kits, Myoglobin Ria Test Kit, Cardiac Markers kits, ...
Lumiquick Diagnostics, Inc. is engaged in the manufacture of care immunoassay kits. Our products include rapid test kits, ELISA and latex tests kits & raw materials. These products provide the immunoa more...
Roche Diagnostics | Address: 9115 Hague Road, P.O. Box 50457, Indianapolis, Indiana 46250, USA
www.roche-diagnostics.us | Phone: +1-(317)-521-2000
Annual Revenues: USD 100-500 Million Employee Count: ~140 Quality: ISO 9000, CE Certified
Products: Blood Glucose Meters, Immunoassay Systems, Immunochemistry Analyzers, Myoglobin (FDA Code: DDR), Lancet Devices, Diagnostic Systems, Lancet, ...
Roche Diagnostics offers diagnostic tests and systems in the area of integrated healthcare solutions. Our products cover the early detection, targeted screening, evaluation and monitoring of the disea more...
www.roche-diagnostics.us | Phone: +1-(317)-521-2000
Annual Revenues: USD 100-500 Million Employee Count: ~140 Quality: ISO 9000, CE Certified
Products: Blood Glucose Meters, Immunoassay Systems, Immunochemistry Analyzers, Myoglobin (FDA Code: DDR), Lancet Devices, Diagnostic Systems, Lancet, ...
Roche Diagnostics offers diagnostic tests and systems in the area of integrated healthcare solutions. Our products cover the early detection, targeted screening, evaluation and monitoring of the disea more...
Bio-medical Products Corp | Address: 10 Halstead Rd, Mendham, New Jersey 07945, USA
www.biomedicalproductscorp.com | Send Inquiry | Phone: +1-(800)-543-7427
Annual Revenues: < USD 1 Million
Products: Creatinine Test Strips, Pregnancy Kits, Drugs Of Abuse Testing Kits, Fertility Monitors, Pregnancy Test Kits, Blood Glucose Test Strips, Home pregnancy test kits, Hcg, ...
Bio-medical Products Corp focuses on drugs of abuse, immunoassays and urinalysis. more...
www.biomedicalproductscorp.com | Send Inquiry | Phone: +1-(800)-543-7427
Annual Revenues: < USD 1 Million
Products: Creatinine Test Strips, Pregnancy Kits, Drugs Of Abuse Testing Kits, Fertility Monitors, Pregnancy Test Kits, Blood Glucose Test Strips, Home pregnancy test kits, Hcg, ...
Bio-medical Products Corp focuses on drugs of abuse, immunoassays and urinalysis. more...
Chembio Diagnostic Systems, Inc. | Address: 3661 Horseblock Road, Medford, New York 11763, USA
www.chembio.com | Send Inquiry | Phone: +1-(631)-924-1135
FDA Registration: 2431980
Products: Chlamydia trachomatis IgA ELISA Kit, Chlamydia trachomatis IgG ELISA Kit, Chlamydia trachomatis IgM ELISA Kit, Chlamydia Trachomatis Real Time PCR Kit, Chlamydia Trachomatis IgG Kit, Chlamydia Trachomatis (FDA Code: MGM), ...
Chembio Diagnostic Systems, Inc. develops and manufactures point-of-care (POC) diagnostic tests and technology for infectious diseases. Our products serve diverse markets that are global. We also expo more...
www.chembio.com | Send Inquiry | Phone: +1-(631)-924-1135
FDA Registration: 2431980
Products: Chlamydia trachomatis IgA ELISA Kit, Chlamydia trachomatis IgG ELISA Kit, Chlamydia trachomatis IgM ELISA Kit, Chlamydia Trachomatis Real Time PCR Kit, Chlamydia Trachomatis IgG Kit, Chlamydia Trachomatis (FDA Code: MGM), ...
Chembio Diagnostic Systems, Inc. develops and manufactures point-of-care (POC) diagnostic tests and technology for infectious diseases. Our products serve diverse markets that are global. We also expo 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...
Fujirebio Diagnostics Inc | Address: 201 Great Valley Pkwy, Malvern, Pennsylvania 19355, USA
www.fdi.com | Send Inquiry | Phone: +1-(610)-240-3800
FDA Registration: 2521625 Year Established: 1998 Annual Revenues: USD 25-50 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Blood Bank Test Kits, Instruments, Immunoassays, Infectious Disease Identification Test Kits, Histology Test Kits, RIA Instruments, Multi Analyte Control (FDA Code: JJY), ...
Fujirebio Diagnostics Inc specializes in diagnostic products. Our product is used to detect the presence of cancer in the blood and sugar. more...
www.fdi.com | Send Inquiry | Phone: +1-(610)-240-3800
FDA Registration: 2521625 Year Established: 1998 Annual Revenues: USD 25-50 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Blood Bank Test Kits, Instruments, Immunoassays, Infectious Disease Identification Test Kits, Histology Test Kits, RIA Instruments, Multi Analyte Control (FDA Code: JJY), ...
Fujirebio Diagnostics Inc specializes in diagnostic products. Our product is used to detect the presence of cancer in the blood and sugar. more...
Oxoid Ltd. | Address: Wade Road, Basingstoke RG24 8PW, United Kingdom 
www.oxoid.com | Send Inquiry | Phone: +44-(1256)-841144
FDA Registration: 8010096 Employee Count: ~400 Quality: ISO 9000, ISO 13485 Certified
Products: Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Anaerobic Transport System (FDA Code: JTX), Antibiotic Assay Culture Media (FDA Code: JSA), Antimicrobial Susceptibility Test Disc (FDA Code: JTN), Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO), Automated Antimicrobial Susceptibility Test System (FDA Code: LON), ...
Oxoid Ltd. manufactures and distributes microbiological culture media & other diagnostic products. Our products are used in clinical and industrial laboratories to isolate and identify the bacteria or more...
www.oxoid.com | Send Inquiry | Phone: +44-(1256)-841144
FDA Registration: 8010096 Employee Count: ~400 Quality: ISO 9000, ISO 13485 Certified
Products: Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Anaerobic Transport System (FDA Code: JTX), Antibiotic Assay Culture Media (FDA Code: JSA), Antimicrobial Susceptibility Test Disc (FDA Code: JTN), Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO), Automated Antimicrobial Susceptibility Test System (FDA Code: LON), ...
Oxoid Ltd. manufactures and distributes microbiological culture media & other diagnostic products. Our products are used in clinical and industrial laboratories to isolate and identify the bacteria or 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...
Zer Hitech (1976) Ltd. | Address: Zer Building, 3 Sorek Park, Jerusalem 99052, Israel
www.zerhitech.com | Send Inquiry | Phone: +972-(2)-9955550
Year Established: 1976 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Thyroid Stimulating Hormone Radioimmunoassay (FDA Code: JLW), Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Hepatitis B Test (FDA Code: LOM), Drugs of Abuse Test Systems (FDA Code: MGX), ...
Zer Hitech (1976) Ltd. specializes in fertility related and infectious disease products. We are associated with diagnostic assays and a network of medical service laboratories servicing hospitals, pri more...
www.zerhitech.com | Send Inquiry | Phone: +972-(2)-9955550
Year Established: 1976 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Thyroid Stimulating Hormone Radioimmunoassay (FDA Code: JLW), Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Hepatitis B Test (FDA Code: LOM), Drugs of Abuse Test Systems (FDA Code: MGX), ...
Zer Hitech (1976) Ltd. specializes in fertility related and infectious disease products. We are associated with diagnostic assays and a network of medical service laboratories servicing hospitals, pri 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...
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FDA Code / Regulation: LTJ / 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.
