Phone: +1 905 304-9896
Fax: +1 905 304-9897

http://www.affinitybiologicals.com

sales@affinitybiologicals.com
Affinity Biologicals, Inc. Figures
Number of employees: 1-19
Year of foundation: 1987
Area of business: iagnostics

Affinity Biologicals, Inc. Profile
Haemostasis and Thrombosis Product Manufacturer

Affinity Biologicals, Inc. is a primary manufacturer of products used worldwide in thrombosis and haemostasis research and medical diagnostics. Products include an extensive line of antibodies, conjugates, antibody matched-pairs for immunoassay of human and animal analytes, the VisuLize line of complete ELISA kits, a full line line of human plasma products including affinity-depleted factor deficient plamsas (Factors II through XIII and all esoteric plasmas), VisuCal Calibrator Plasmas and VisuCon Normal and Abnormal Control Plasmas. Our custom services include protein purification, antibody production, assay development, proficiency testing materials and custom manufacturing/lyophilisation.

Affinity’s quality system is registered to ISO 13485:2003 and is USFDA QSR compliant, a registered medical device manufacturer with the United States FDA, the Canadian Therapeutic Products Directorate (TPD), the European Regulatory Authorities (CE Mark) and the Indian Ministry of Health (CDSCO).

Affinity Biologicals, Inc. Product Information
Product Categories
Haemostasisreagents (Coagulation)

Product Information of Product Category Haemostasisreagents (Coagulation)
OEM – Bulk Factor Deficient Plasmas
Bulk – Plasma Products In Frozen and Lyophilized Formats

Affinity Biologicals Inc. may be best known for affinity-purified antibodies and ELISA kits, but a significant portion of our manufacturing activity is the production of disease-state plasmas and controls. We have expanded our plasma manufacturing capacity to include lyophilized product. As a major supplier of bulk intermediates for use in diagnostics manufacturing, we now offer the industry our high quality immune-depleted coagulation factor-deficient and esoteric plasma products in either frozen or lyophilized formats.

We appreciate that in diagnostics the performance and reliability of raw and intermediate materials are of paramount concern. Affinity has been a primary manufacturer of factor-deficient plasmas and controls for more than 10 years. We work cooperatively with customers to meet their product performance specifications in an achievable and consistent manner, a strategy that has resulted in an excellent customer retention rate.

In addition to the factor deficient plasmas, we also manufacture a variety of other plasma products (see list), including hard to find products such as Kininogen deficient plasma. Affinity also manufactures specialty products on a custom basis, such as D-dimer controls, high fibrinogen controls and purified proteins (B2Glycoprotein-I and Antithrombin to name a few). All plasma used in production is of USA origin and tested negative for Hepatitis-B, HCV and HIV. All antibodies are sourced internally.

VisuCon-F Frozen Abnormal Control Plasma
Intended for use in the quality control of coagulation assays in the abnormal range. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. The VisuCon™-F Frozen Abnormal Control Plasma is an abnormal pooled citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02M HEPES buffer, dispensed and rapidly frozen. This control plasma may be used to monitor the performance of coagulation assays for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, and XII, antithrombin, Protein C, and Protein S.

Product Features:
This product is FDA cleared, Health Canada approved, CE marked and approved by the Indian Ministry of Health for in vitro Diagnostic use.

Each box of VisuCon™-F Frozen Abnormal Control Plasma contains a lot specific Certificate of Analysis with reference values for each parameter.

Frozen Control Plasmas are easily thawed and compatible with all coagulation analyzing equipment.

VisuCon-F Frozen Normal Control Plasma
Intended for use in the quality control of coagulation assays in the normal range. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. The VisuCon™-F Frozen Normal Control Plasma is normal pooled citrated human plasma collected from a minimum of 20 donors, buffered with 0.02M HEPES buffer, dispensed and rapidly frozen. This control plasma may be used to monitor the performance of coagulation assays for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, and XII, antithrombin, Protein C, and Protein S.

Product Features:
This product is FDA cleared, Health Canada approved, CE marked and approved by the Indian Ministry of Health for in vitro Diagnostic use. Each box of VisuCon™-F Frozen Normal Control Plasma contains a lot specific Certificate of Analysis with reference values for each parameter.Frozen Control Plasmas are easily thawed and compatible with all coagulation analyzing equipment.

VisuLize Factor VIII Antigen ELISA Kit
The VisuLize™FVIII Antigen Kit is intended to quantitatively measure factor VIII in human plasma and factor concentrates. The biological importance of factor VIII is demonstrated in Hemophilia A and those patients suspected of thrombophilia. The laboratory diagnosis of factor VIII deficiency in Hemophilia A typically involves quantitative determination of factor VIII’s functional activity. The use of this kit in conjunction with functional assays in the area of gene therapy, assessment of factor VIII concentrates, as well as distinguishing those patients with cross-reactive material will prove useful in the area of Hemophilia A. Additionally as documented in numerous studies, elevated levels of factor VIII is being recognized as a common risk of venous thrombosis¹, an area where Affinity’s VisuLize™ FVIII Antigen Kit has utility.

The VisuLize™ FVIII Antigen Kit is FDA cleared, Health Canada approved, CE marked and approved by the Indian Ministry of Health.

Features:
•Rapid sandwich ELISA to measure FVIII antigen (FVIII:Ag)
•1 hour 55 minutes total incubation time!
•FVIII:Ag reported as International Units/ml traceable to WHO standard for FVIII antigen
•Detection limit to 0.008 IU/ml FVIII:Ag (0.8%)
•Includes normal and low controls
•Shelf-life: 18 months

Applications:
•Quantification of FVIII in plasma and therapeutic concentrates
•Diagnosis and characterization of Hemophilia A
•Carrier testing for Hemophilia A
•Thrombophilia screening

Phone: +1 514 273-5972
Fax: +1 514 273-4925

http://www.web-texinc.com

rweber@web-texinc.com

Web-Tex Inc Company Figures
Number of employees: 50-99
Sales volume: 10-49 Mio US $
Year of foundation: 1985
Area of business:
■ Commodities and Consumer Goods for Surgeries and Hospitals

Web-Tex Inc Company Contacts
Department/ Name Contact / e-Mail
Robert Weber Tel: (514) 273-5972, Fax: (514) 273-4925
webtex@total.net

Web-Tex Inc Company Profile
Web-Tex Inc was founded in 1985 and has continuously grown to become a leading manufacturer of all types of medical, orthopedic bandages and surgical dressings. All of Web-Tex’s products are developed, patented and made in Canada. They include elastic bandages, stretch gauzes, gauze pads, stockinets, self-adherent bandages and shoe covers.
Web-Tex’s product line uses the finest material and offers an array of widths and sizes.

Web-Tex Inc Product Categories
Bandage materials
Bandages
Elastic bandages
Plaster of Paris bandages
Netting bandages
Plasters
Tube bandages
Other bandages, dressings and accessories
Stump stockings
Surgical packs
Stockinet bandages
Bandaging materials
Bandaging sets, operation sets