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Alpha-Fetoprotein for Testicular Cancer Test Kit Suppliers

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 EMAIL INQUIRY to  13 suppliers  
Diagnostic Automation, Inc. | Address: 23961 Craftsman Rd. Suite E/F, Calabasas, California 91302-2521, USA USA
www.rapidtest.com/index2.htm | Send Inquiry | Phone: +1-(818)-591-3030
Products: 17-OH Progesterone Kit, 11-keto Testosterone EIA Kit, 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA), Aldosterone Radioimmunoassay Test (FDA Code: CJM), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO), 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL), ...
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...
 
Biocheck, Inc. | Address: 323 Vintage Park Dr., Foster City, California 94404, USA 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...
Siemens Healthcare Diagnostics | Address: 1717 Deerfield Road, Deerfield, Illinois 60015-0778, USA 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...
Ortho-clinical Diagnostics, Inc. | Address: 100 Indigo Creek Drive, Rochester, New York 14626, USA USA
www.orthoclinical.com | Send Inquiry | Phone: +1-(800)-828-6316
FDA Registration: 1319809  Year Established: 1937
Products: Immunoassay Systems, Troponin I, Myoglobin (FDA Code: DDR), Hepatitis B Surface Antibody Test Kits, Hepatitis B Surface Antigen Test Kits, Hepatitis C Antibody 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...
Diagnostic Systems Laboratories, Inc. | Address: 445 Medical Center Blvd., Webster, Texas 77598, USA USA
www.dslabs.com | Send Inquiry | Phone: +1-(281)-332-9678
Year Established: 1981  Annual Revenues: USD 10-25 Million  Employee Count: ~110  Quality: ISO 9001, CE Certified
Products: Calcitonin, 17-OH Progesterone Kit, 17- Dehydroxy Progesterone Testing Set, Calcitonin Assay Immunoradiometric (IRMA) Assay, 11-keto Testosterone EIA Kit, Blood Bank Test Kits, ...
Diagnostic Systems Laboratories, Inc. develops and markets in vitro diagnostics. We are an ISO 9001, CE MARK & ISO 13485 certified company. Our DSL active cortisol (saliva) EIA is optimized specifical more...
Beckman Coulter, Inc. | Address: 4300 N. Harbor Boulevard P.O. Box 3100, Fullerton, California 92834-3100, USA 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: Hematology Analyzers, Blood Analyzer Reagents, Chemistry Analyzers, Controls for Diagnostic Equipment, Hematology Reagents, General Diagnostic Supplies, ...
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...
Abbott Hematology | Address: 5440 Patrick Henry Dr., Santa Clara, California 95054, USA USA
www.abbott.us | Phone: +1-(408)-982-4800
FDA Registration: 2919069  Employee Count: ~72000  Quality: ISO 9001, CE Certified
Products: Diagnostic Instruments, Diagnostic Test Kits, Medical Devices, Coronary Guide Wires, Topical Hemostasis Pad, Suture Trimmer, ...
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 USA
Phone: +1-(724)-539-1833
FDA Registration: 2530112
Products: ACTH Radioimmunoassay Test (FDA Code: CKG), C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD), Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ), Alpha-Fetoprotein for Testicular Cancer Test Kit (FDA Code: LOJ), Beta-2-Microglobulin Immunological Test System (FDA Code: JZG), C-Reactive Protein Test System (FDA Code: DCN), ...
Carclo Technical Plastics is associated with immunoassay tests. 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: Tartrate Inhibited Acid Phosphatase (FDA Code: JFH), C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD), Data Processing Module for Clinical use (FDA Code: JQP), Fluorometer for Clinical Use (FDA Code: KHO), Cortisol Fluorometric Test (FDA Code: JFT), Creatinine Enzymatic Method Test (FDA Code: JFY), ...
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: Natriuretic Peptide Test (FDA Code: NBC), Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer Total (FDA Code: MTF), Antimicrobial Susceptibility Test Cards (FDA Code: LTW), Digoxin Antiserum (FDA Code: DKA), Sepsis Inflammatory Response Marker Antigen (FDA Code: NTM), Fluorometers (FDA Code: JZT), ...
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...
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: Lipoproteins Turbidimetric Method Test (FDA Code: JHN), Nadh Oxidation/Nad Reduction (FDA Code: CKA), Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ), Ast/Sgot Nadh Oxidation/Nad Reduction (FDA Code: CIT), Cardiac C-Reactive Protein Antiserum Antigen Control (FDA Code: NQD), Rhodamine Transferrin Antiserum Antigen Control (FDA Code: DDD), ...
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 Mannheim | Address: Sandhofer Strasse 116, Mannheim D-68305, Germany Germany
FDA Registration: 9610529
Products: Automated Urinalysis System (FDA Code: KQO), Radioimmunoassay for Dehydroepiandrosterone Sulfate (FDA Code: JKC), Estradiol Radioimmunoassay Test (FDA Code: CHP), Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ), Hydroxyproline Chromatography Column Test (FDA Code: JMM), Total Triiodothyronine Radioimmunoassay (FDA Code: CDP), ...
Roche Diagnostics Gmbh Mannheim is a provider of automated urinalysis system and cardiac readers. more...
Roche Diagnostics Gmbh | Address: Sandhoferstrasse 116, Mannheim D-68298, Germany Germany
www.roche.com | Phone: +49-(621)-759 0
FDA Registration: 9610126
Products: Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS), Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU), Solid Phase Rabbit Digoxin (125-I) Radioimmunoassay Test (FDA Code: DON), Cyclosporine and Metabolites Serum Assay (FDA Code: MAR), Cyclosporine (FDA Code: MKW), Digoxin (125-I) Radioimmunoassay (FDA Code: LCS), ...
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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 EMAIL INQUIRY to  13 Alpha-Fetoprotein for Testicular Cancer Test Kit suppliers  
FDA Code / Regulation: LOJ / 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.

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