Affinity Biologicals, Inc.

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Contact: Greg Fullerton - Manager, Sales & Marketing
Web: http://www.affinitybiologicals.com
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Address: 1395 Sandhill Dr., Ancaster, Ontario L9G 4V5, Canada
Phone: +1-(905)-304-9896 | Fax: +1-(905)-304-9897 | Map/Directions >>

Profile: Affinity Biologicals, Inc. is a manufacturer of products used in thrombosis and haemostasis research and medical diagnostics. Products include an extensive line of antibodies, conjugates, antibody pairs for immunoassay of human and animal analytes, the VisuLizeT line of complete ELISA kits, and a full line of human plasma products including affinity-depleted factor-deficient plasmas (factors II through XIII, PC, PS, ATIII), VisuCal Tcalibrator plasmas and VisuConT control plasmas. Services include protein purification, antibody production, assay development, custom manufacturing & custom lyophilization and proficiency testing materials. We are registered to ISO 13485(2003) and USFDA QSR compliant. We are also a registered medical device manufacturer with the US FDA, the Canadian Therapeutic Products Directorate (TPD) and the European regulatory authorities (CE Mark).

The company was founded in 1987, has revenues of USD 1-5 Million, has ~20 employees and is ISO 13485:2003 certified.

FDA Registration Number: 3003485232
US Agent: Rene Van De Zande / Emergo Global Representation Llc
Phone: +1-(512)-327-9997 Fax: +1-(512)-327-9998 E-Mail:

19 Products/Services (Click for related suppliers)

• 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).

• Coagulation Factors

• Enzyme Immunoassay

• Factor XIII A (FDA Code: DBT / 866.5330)

A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.

• 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)

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150)

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• 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 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.

• 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 & Control Partial Thromboplastin Time (FDA Code: GIT / 864.7925)

• 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.