Custom Quality Control Materials

Sun Diagnostics can create customized, unassayed QC materials for your assay, to your specifications.


60 Pineland Drive Brunswick Hall
Suite 322
New Gloucester, ME 04260

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Call Us

(877) SUN-DIAG

Email Us


Mon-Fri: 8am-8pm
Sat & Sun: Closed

Our customized development service and materials are ideal for:

  • Manufacturers: SunDx QC materials are human serum- based and more similar to patient samples. Our materials can be prepared independently of the assay calibration materials, providing an independent assessment of assay and instrument performance. We are flexible and can accommodate small, medium and large batch sizes, to be packaged either at our facility or shipped in bulk to you.
  • Laboratories: SunDx QC material provides an independent, 3rd party evaluation of your assay and instrument system, with a human serum-based matrix more similar to patient samples. Whether your laboratory is looking to replace the manufacturer’s QC material or to supplement it with QC at levels different than what the manufacturer can provide, SunDx can help meet your needs with liquid, ready-to-use materials.
  • Researchers: SunDx QC materials can be made to your specifications, for your “home-brew” assays or at different levels than are normally provided with a commercially available assay you are using. We are flexible and can accommodate small lot sizes or can manufacture larger batches that you can use throughout your experiments / studies, without the added variable of changing QC lots.

FDA registered facility

Sun Diagnostics, LLC is an FDA registered facility with a strong focus on product quality and customer satisfaction.

SunDx + FDA = Quality Assurance

Our Quality Control Process

Custom Solutions

Personalized Service

Straightforward Process

The process is straightforward. Simply call or email to setup a time to discuss your project with members of our design team. The team will gather your information and prepare a proposal that includes your requirements (analyte(s), matrix, ranges, volume, packaging, etc.) which will be sent to you for approval.

In addition to creating customized quality control materials, we welcome the opportunity to discuss other custom development and production projects with you.

Unassayed QC Materials for your Assay

Tell us what your specifications are, and let us create a fully customized product to meet your needs.

IVD Products for:



Human serum-based for proper patient sample comparisons.



Providing independent third party evaluations of assays and instruments.



Custom solutions for cutting edge biological queries.

The Best In Vitro Diagnostic System Designed Only For You

While we have a line of specialized products for the In Vitro Diagnostic Industry, we welcome opportunities to work with fellow scientists in conceptualizing, creating, and perfecting even more production products. Our goal is straight forward: the advancement and improvement of medicine.


Product Lines



Contact us

Call Us

(207) 926-1125
(877) SUN-DIAG

Our Location

60 Pineland Drive Brunswick Hall
Suite 322
New Gloucester, ME 04260