GTI Diagnostics
Web: http://www.gtidiagnostics.com
E-Mail:
Address: 20925 Crossroads Circle, Suite 200, Waukesha, Wisconsin 53186, USA
Phone: +1-(262)-754-1000 800.233.1843 | Fax: +1-(262)-754.9831 | Map/Directions >>
Profile: GTI Diagnostics develops & manufactures medical diagnostic assays for the transplantation, blood bank and coagulation laboratories. Our product area includes blood bank, ELISA and molecular products. The PakAuto® is designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma. The Pakplus® is designed to identify antibodies to specific epitopes on the platelet glycoproteins. The Pak®12 provides platelet glycoproteins immobilized either directly and captured by monoclonal antibodies to the wells of a microwell plate. The Mace®1 is designed to detect IgG antibodies to HLA Class I antigens, and to epitopes on the platelet glycoprotein IIb/IIIa.
The company is ISO 13485:2004 ISO 13485:2003 CEMARK certified.
FDA Registration Number: 2183608
13 Products/Services (Click for related suppliers)
|
| • Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to: |
| • Automated Blood Grouping and Antibody Test System (FDA Code: KSZ / 864.9175) An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens. |
| • Human Chromosome DNA-Probe (FDA Code: MAO) |
| • Invitro Diagnostic Potentiating Media (FDA Code: KSG / 864.9600) Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing. |
| • Leukocyte Typing Test (FDA Code: LGO / 864.7675) A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias. |
| • Molecular Analyte Specific Reagents (ASR) |
| • Non-Diagnostic Qualitative Test For Hla (FDA Code: MZI) |
| • Non-sterile Empty Tissue Typing Trays |
| • Platelet Antibody Test (FDA Code: MYP) |
| • Platelet Associated IGG Kit (FDA Code: LLG / 864.5425) |
| • Platelet Factor 4 Radioimmunoassay (FDA Code: LCO / 864.7695) A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease. |
| • Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290) A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene). |
| • Sterile Empty Tissue Typing Trays |
