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Contract Manufacturing & OEM
We specialise in contract and custom manufacturing for immunohaematology products
For diagnostic organisations, manufacturing decisions are rarely simple. You need technical expertise, quality systems, regulatory understanding, and a partner who can work with the details behind your product.
Immulab provides contract and custom manufacturing services for diagnostic manufacturers and medical device organisations, with specialist expertise in immunohaematology reagents.
Our Facilities & Quality
Manufacturing quality you can build your business around.
Immulab’s leading Australian manufacturing and R&D facilities are licensed and audited by the Therapeutic Goods Administration.
Immulab maintains a Quality Management System audited to AS EN ISO 13485:2016 standards.
When consistency matters: Monoclonal concentrates
When you’re developing or manufacturing immunohaematology products, consistency at the component level matters. Immulab provides intermediate monoclonal blood typing antibodies for further manufacturing use.
Produced from cell lines secreting human or murine monoclonal antibodies, these concentrates support reliable specificity and comparable batch potency. Potencies are assessed against reference preparations, giving diagnostic manufacturers specialist inputs without developing every component from the ground up.
Biomedical Maintenance
Blood Group Reagents
Support blood group testing with reagents manufactured for immunohaematology, blood bank, and pathology settings. Immulab works with diagnostic organisations that need reliable product supply, technical knowledge, and quality-led manufacturing behind their reagent range.
Discover how ParagonCare can assist your organisation.
Equipment Contracts
Anti-Glycophorin A
Support specialist immunohaematology applications with Anti-Glycophorin A reagent expertise. Immulab works with diagnostic manufacturers to support technical requirements, product documentation, manufacturing needs, and quality expectations.
Ask About Anti-Glycophorin A
Blood Group Reagents
Support blood group testing with reagents manufactured for immunohaematology, blood bank, and pathology settings. Immulab works with diagnostic organisations that need reliable product supply, technical knowledge, and quality-led manufacturing behind their reagent range.
Discover how ParagonCare can assist your organisation.
Anti-Glycophorin A
Support specialist immunohaematology applications with Anti-Glycophorin A reagent expertise. Immulab works with diagnostic manufacturers to support technical requirements, product documentation, manufacturing needs, and quality expectations.
Ask About Anti-Glycophorin A
Bring proven blood typing reagents to market under your own brand
Immulab offers a wide range of blood typing reagents in bulk quantities and standardised vials. ABO and RhD reagents are available in bulk, as well as ready-for-use vialled formats. Depending on quantities required, selected products may also be labelled in your own trade dress, with support available for regulatory submissions. This gives diagnostic organisations a practical way to expand their product range without building specialist manufacturing capability from the ground up.
Blood Group Reagents
Support routine blood group testing with reagents manufactured for immunohaematology laboratories.Immulab works with diagnostic organisations that need reliable product supply, technical support, and quality-led manufacturing for blood bank applications.
AGH Reagents
Support confident compatibility testing with AHG reagents manufactured for blood bank and immunohaematology applications.
Immulab provides product supply, technical support, and manufacturing expertise for diagnostic organisations managing routine and specialist testing workflows.
Phenotyping Reagents
Support extended blood group typing with phenotyping reagents manufactured for diagnostic and pathology use. Immulab works with partners who need product knowledge, quality expectations, and specialist immunohaematology manufacturing behind their reagent supply.
Reagent Red Blood Cells
Support complex testing with reagent red blood cells manufactured for blood bank and pathology settings. Immulab provides technical and applications expertise to help customers manage performance, quality, and unusual testing requirements when they arise.
Blood Group Reagents
Blood Group Reagents
Support routine blood group testing with reagents manufactured for immunohaematology laboratories.Immulab works with diagnostic organisations that need reliable product supply, technical support, and quality-led manufacturing for blood bank applications.
AGH Reagents
AGH Reagents
Support confident compatibility testing with AHG reagents manufactured for blood bank and immunohaematology applications.
Immulab provides product supply, technical support, and manufacturing expertise for diagnostic organisations managing routine and specialist testing workflows.
Phenotyping Reagents
Phenotyping Reagents
Support extended blood group typing with phenotyping reagents manufactured for diagnostic and pathology use. Immulab works with partners who need product knowledge, quality expectations, and specialist immunohaematology manufacturing behind their reagent supply.
Reagents Red Blood Cells
Reagent Red Blood Cells
Support complex testing with reagent red blood cells manufactured for blood bank and pathology settings. Immulab provides technical and applications expertise to help customers manage performance, quality, and unusual testing requirements when they arise.
Build everyday confidence into quality control and competency testing
Quality control is part of everyday confidence in the laboratory. Immulab’s Blood Group Serology control reagents help users validate and control testing on an individual or batch basis.
The range includes products suitable for blood grouping platforms, as well as simulated whole blood control samples that support diagnostic confidence and versatility in immunohaematology laboratories. Immulab also manufactures a system using Kode™ CA technology to create controlled antigen expression, supporting an unbiased challenge to blood bank systems and a true third-party quality control option.
Frequently Asked Questions
Who is Immulab?
Immulab is part of ParagonCare and specialises in the manufacture of immunohaematology reagents for blood bank, pathology, and diagnostic use. Its Australian manufacturing and R&D facilities are licensed and audited by the Therapeutic Goods Administration, with a Quality Management System audited to AS EN ISO 13485:2016 standards.
What is contract manufacturing?
Contract manufacturing means Immulab can manufacture using your formulation, specifications, and label. This helps diagnostic organisations bring products to market without building or expanding specialist manufacturing capability internally.
What is OEM support?
Original Equipment Manufacturing (OEM) support means Immulab may provide its own products or formulations under your organisation’s brand. This gives diagnostic organisations access to established immunohaematology products, supported by manufacturing expertise, technical knowledge, and regulatory understanding.
Does Immulab manufacture in Australia?
Yes. Immulab manufactures in Australia, with manufacturing and R&D facilities licensed and audited by the Therapeutic Goods Administration.
What quality standards does Immulab work to?
Immulab maintains a Quality Management System audited to AS EN ISO 13485:2016 standards.
Can Immulab support products under our own brand?
Yes. Depending on quantities required, selected products may be labelled in your own trade dress. Please reach out to our team to discuss your needs and requirements.
Can Immulab support regulatory submissions?
Yes. Depending on the product, quantity, and market requirements, Immulab may be able to assist with documentation or information needed to support regulatory submissions.
What types of organisations does Immulab support?
Immulab supports diagnostic manufacturers, medical device organisations, pathology providers, and organisations bringing immunohaematology products to market.
