Bio/data Corporation

Address: 155 Gibraltar Road,P.O.Box 347, Horsham, Pennsylvania 19044-0347, USA
Phone: +1-(215)-441-4000, 800-257-3282 | Fax: +1-(215)-443-8820 | Map/Directions >>

Profile: Bio/data Corporation specializes in pre-analytical sample preparation utilizing microfiltration, aggregometers, coagulation instrumentation and reagents. We are an ISO certifide company. Our Microsample Coagulation Analyzer™ series of coagulation instruments incorporate microfiltration technology for automated sample preparation, reducing turn-around-time, automating 95% of the routine coagulation workload while minimizing sample and reagent consumption. Our MCA 310 is a fully automated, random access coagulation analyzer capable of performing a plasma-based PT, APTT and a kinetic fibrinogen. Our cephalinex® is a lyophilized preparation of rabbit brain cephalin and particulate activator.

FDA Registration Number: 2517686

38 Products/Services (Click for related suppliers)  
• Activated Partial Thromboplastin (FDA Code: GFO / 864.7925)
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
• Aggregometers
• Automated Coagulation Analyzer (FDA Code: GKP / 864.5400)
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
• Automated Coagulation Instrument (FDA Code: GKP / 864.5400)
• Automated Platelet Aggregation System (FDA Code: JOZ / 864.5700)
An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
• Biohazard Disposable Bags
• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)
• Cell Waste Container
• Coagulation Analyzer with Timer (FDA Code: GKP / 864.5400)
• Coagulation Analyzers (FDA Code: GKP / 864.5400)
• Coagulation Factor Deficient Plasma (FDA Code: GJT / 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).
• Coagulation Timer (FDA Code: JBT / 864.5400)
• Disposable Pipette Tips, Non-sterile Disposable Tips
• Disposable Reagent Set
• Disposable Reagent System
• Disposable Stir
• Fibrinogen Control Plasma (FDA Code: GIL / 864.7340)
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
• Fibrinogen Determination System Test (FDA Code: KQJ / 864.7340)
• Fibrinogen Test (FDA Code: GIS / 864.7340)
• Fully Automated Random Access Coagulation Analyzer
• Laboratory Coagulation Analyzers
• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 864.5425)
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
• Normal Control Plasma (FDA Code: GIZ / 864.5425)
• Partial Thromboplastin Test Time (FDA Code: GGW / 864.7925)
• Plasma Coagulation Control (FDA Code: GGN / 864.5425)
• Plasma Test Vial
• Platelet Aggregation Reagents (FDA Code: GHR / 864.5700)
• Platelet Aggregation Systems
• Platelet Aggregometer (FDA Code: JBX / 864.6675)
A platelet aggregometer is a device, used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet rich plasma.
• POC Coagulation Analyzers (PT and INR)
• Point-of-care (POC) Coagulation Analyzers
• Prothrombin Time Test (FDA Code: GJS / 864.7750)
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290)
• Reagent Collector Pads
• Test Tubes
• Thrombin Time Test (FDA Code: GJA / 864.7875)
A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
• Thrombokinetogram Platelet Aggregometer (FDA Code: GKW / 864.6675)
• Vertical Stirring System

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