Precision Biologic, Inc.
Contact: Trina Kilpatrick - Marketing Coordinator
Web: http://www.precisionbiologic.com
E-Mail:
Address: 140 Eileen Stubbs Avenue, Dartmouth, Nova Scotia B3B 0A9, Canada
Phone: +1-(902)-468-6422, 800-267-2796 | Fax: +1-(902)-468-6421 | Map/Directions >>
Profile: Precision Biologic, Inc. manufactures a range of products used in clinical coagulation laboratories. We offer various types of diagnostic kits, reagents and controls & specialty plasmas. The diagnostic kits are C & S diluent, Cryocheck™ Clot S™, Clot C™, Chromocheck™ antithrombin and chromocheck protein C. Our Cryocheck Clot S is a clot-based assay presented in a frozen format and intended for the quantitative determination of protein S activity in citrated human plasma. It initiates the common pathway of coagulation in plasma using a Russell's viper venom reagent to convert factor X to Xa in the presence of activated protein C, bypassing all factors above the common pathway. The Chromocheck antithrombin is a chromogenic assay intended for the quantitative determination of antithrombin activity in citrated human plasma. Our controls and specialty plasma products include Cryocheck pooled normal plasma, normal sonor set, normal reference plasma, abnormal 1 reference control, and lupus positive control.
The company was founded in 1983, has ~30 employees and is ISO 9001, CE certified.
FDA Registration Number: 8043599
US Agent: Gordon Ens / Ens Consulting Group, Llc
Phone: +1-(316)-680-3330 E-Mail:
14 Products/Services (Click for related suppliers)
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| • Abnormal Plasma Control (FDA Code: GGC / 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. |
| • 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: |
| • Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060) An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III). |
| • 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). |
| • 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 Standard and Control (FDA Code: GFK / 864.7340) |
| • Fibrinogen Standard (FDA Code: GFX / 864.7340) |
| • Molecular Analyte Specific Reagents (ASR) |
| • Normal Control Plasma (FDA Code: GIZ / 864.5425) |
| • Partial Thromboplastin Test Time (FDA Code: GGW / 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. |
| • Plasma Coagulation Control (FDA Code: GGN / 864.5425) |
| • Platelet Aggregation Reagents (FDA Code: GHR / 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. |
| • Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290) |
| • Russel Viper Venom Reagent (FDA Code: GIR / 864.8950) Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time. |
