In Vitro Diagnostic Reagents for IVD Assay Development

From early assay design through production, Pel-Freez helps in vitro diagnostic test developers reduce risk with reliable, well-characterized biological reagents. Our blood products, complement, sera, and tissues are known worldwide for quality and consistency.

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Key applications we support

Coagulation assays

With rabbits raised on our own US farms and a trusted supplier network, Pel-Freez is a reliable source of rabbit brain acetone powder, rabbit brain cephalin, and other biologicals for the development and manufacturing of in vitro coagulation assays.

Serological testing

Pel-Freez offers a broad range of stocked and custom biological products that support serological IVD assay development. Use our materials as diluents or active components in tissue typing, autoimmune panels, metabolic testing, and more.

Infectious disease testing

Our human and animal blood products support reliable, clinically relevant evaluation of immune responses or pathogen-associated indicators of disease. Large lot sizes and reservable inventory help maintain consistency across validation studies and product batches.

Immunoassays and antigen detection

Reduce background and improve specificity with human IgG-, IgM-, and IgA-depleted sera. We also offer blocking sera, tissue extracts, and high-purity biological reagents from multiple species to support your EIA/RIA, ELISA, lateral flow, and other IVD assay development needs.

Controls, stabilizers, and kit validation

Establish assay integrity and regulatory compliance with ethically sourced biological materials for use as positive and negative controls, matrix-matched samples, and lot-to-lot verification standards.

Need a custom reagent for your kit?

Need a custom reagent for your kit?

We offer custom dissection/tissue procurement, antiserum, lyophilization, and other bioprocessing services. Our team follows strict QC processes to help you build reliable, scalable in vitro diagnostic testing protocols and kits.

See custom capabilities

Why IVD developers choose Pel-Freez

We help you build better tests with consistent reagents and a supply you can count on.

  • Decades of experience supporting IVD assay development and production
  • Trusted by leading CROs, biotech, and pharmaceutical labs
  • Dependable performance driven by rigorous sourcing and QC standards
  • Batch testing and lot reservation that reduce risk during validation

Results start with the right materials

Start your next project with the products and support trusted by scientific teams around the world.

What researchers say about Pel-Freez

  • “Pel-Freez is our go-to provider of essential reagents such as Lyophilized Rabbit complement and immunoglobulin-depleted human serum. These quality products allow us to perform our in-house opsonophagocytic killing assay (OPK/OPA) and move rapidly on product development.”

    Dr. Joseph E. MartinezPresident, Immune Diagnostics
  • “Our clinical immunology laboratory has used Pel-Freez Universal Human Male AB Serum before and we have been very pleased with its performance, so we set it up as a long-term standing order.”

    Team Leader, Clinical ImmunologyMajor U.S. Health System Laboratory
  • “The Human AB Sera lot we purchased was excellent for our histocompatibility work because it was negative for HLA antibodies. I appreciate the customer service and we intend to be repeat customers.”

    John Fisher, M.S., CHT (ACHI), MT (ASCP)Lab Supervisor, Histocompatibility and Flow Cytometry, The University of Toledo
  • “Pel-Freez goat IgG worked great in our assay, and being able to reserve the balance of a lot while we tested it made qualification straightforward.”

    Product ScientistImmunoassay Kit Manufacturer, United States
What is the difference between item 41110 and 41170 rabbit brain acetone powders?
Each of these rabbit brain acetone powders begins with a frozen rabbit brain as the raw material prior to acetone drying and powder production. Code 41170 includes barium sulfate during processing while code 41110 does not. Barium sulfate acts to bind clotting factors which may speed coagulation, thus code 41170 has increased sensitivity to clotting deficiencies.
Can I order products from a single lot? Can I order products from several different lots?
Yes, you can request products that originate from a single lot or from several different lots. We are usually able to accommodate these requests but availability may vary due to maximum lot volumes for certain products. We try to maintain a minimum inventory of ten 5+ liter baby rabbit complement (BRC) lots at all times so that customers have options to select from. We recommend that you contact us directly with your request on our contact page or by emailing biosales@pel-freez.com.
May I receive a sample of your products? Will you hold a reserve of the product while I complete my testing?
Yes. Most of our products are tested in the customer's own assay before purchase, so we are happy to provide samples and to hold a reserve of the lot for up to 30 days while you test. Lots often have several inquiries at once, but we do our best to fulfill every request.
How does Pel-Freez support in vitro diagnostic (IVD) assay development?
We supply raw biological materials (blood products, sera, extracts, tissues, etc.) that are used in IVD assays to detect proteins, antibodies, infectious agents, and coagulation markers. Our human- and animal-derived materials have been used by leading pharma and biotech companies as essential components, controls, and validation samples across R&D and manufacturing stages.