OEM
In addition to the finished product, Immulab can provide a full range of custom and contract manufacturing services for the diagnostic manufacturer. Our comprehensive range of products and services meet the development and production needs of medical device manufacturers and diagnostic organisations around the globe. Our expertise in product R&D, project management, contract manufacturing, troubleshooting, and material validation and optimisation can assist your organisation to meet your manufacturing goals whilst meeting regulatory standards, lowering capital investment and human resource requirement.
Immulab’s world class Australian manufacturing and R&D facilities are licensed and audited by the Therapeutics Goods Administration (TGA). Immulab has a Quality Management System which is audited to AS EN ISO 13485:2016 standards.
Product Range
- Monoclonal Concentrates For Further Manufacturing Use (FFMU)
- Blood Grouping Reagents
- Including Anti-Glycophorin A
- Ready for use bulk or vialled reagents
- Blood Grouping Reagents
- AHG Reagents
- Phenotyping Reagents
- Reagent Red Blood Cells
- Quality Control Product & Competency
FFMU Product Range
Immulab provides a range of intermediate monoclonal blood typing antibodies for further manufacturing use (FFMU) from cell lines secreting human or murine monoclonal antibodies. Since these are derived from hybridoma cell lines producing monoclonal antibodies each batch will have comparable potencies and identical specificity. (Potencies are assessed against reference preparations.)
Quality Control and Competency
This range of Blood Group Serology (BGS) control reagents enable the user to validate and control testing on an individual or batch basis. Our range includes products suitable for control of blood grouping platforms, as well as simulated whole blood control samples that sets new benchmarks in diagnostic confidence and versatility in the Immunohaematology laboratory. Immulab manufactures the only system that uses innovative Kode™ CA technology to create controlled antigen expression. This ensures an unbiased challenge to any blood bank system, a true third Party QC you can trust.
Ready for Use Bulk or Vialled Reagents
Immulab has a wide range of blood typing reagents, which meet regulatory standards in various jurisdictions. ABO & RhD reagents are offered in bulk quantities, as well as standardised vials. Depending on the quantities required, Immulab can label these products in your own trade dress and assist with regulatory submissions.
Contact us for more information
Mary-Jane O’Sullivan
General Manager - Diagnostic & Scientific Group
M: +61 455 552 593 E: mary-jane.osullivan@paragoncare.com.au
Claire Grattidge
Business Unit Manager - Diagnostic & Scientific Group
M: +61 428 591 604 E: claire.grattidge@paragoncare.com.au