Your brand. Our proven platform. Built for point-of-care and clinical diagnostic programs.
Detekt’s OEM lateral flow reader for medical diagnostics supports clinical and point-of-care programs that demand performance, regulatory alignment, and a platform that can scale alongside a growing test menu. Whether you’re developing a CLIA-waived rapid test, expanding an IVD portfolio, or looking for a validated reader platform to support a regulatory submission, Detekt provides a clear path to a branded, clinically-ready solution.
Our OEM program is designed for medical diagnostic companies at every stage — from early assay development through commercial launch and beyond.
Detekt’s lateral flow reader platforms are designed with IVD regulatory submissions in mind. Our OEM program includes the documentation, validation support, and US-based manufacturing traceability that regulated medical diagnostic programs require — whether you’re pursuing CLIA waiver, 510(k) clearance, or international regulatory approval. Our platforms have supported clinical diagnostic programs through regulated deployment across global markets.
Point-of-care diagnostics increasingly demand more than a visual positive or negative. Detekt’s optical reader platforms deliver objective, quantitative line intensity measurement — eliminating operator subjectivity and providing documented, auditable results that support confident clinical decision-making. Our readers are configurable with assay-specific result algorithms, cutoff values, and connectivity to EHR and laboratory information systems.
Start white-label with the RDS-2500 or RDS-3500 FLEX and scale to fully custom hardware as your IVD program grows — without reengineering your core workflow. Detekt’s OEM structure is built to evolve alongside your diagnostic program, from early assay validation through commercial launch and post-market expansion, with US-based manufacturing and long-term product lifecycle commitment at every stage.
Detekt’s OEM lateral flow reader for medical diagnostics supports IVD companies at every stage of development — from early-stage startups developing a first point-of-care assay, to established diagnostic manufacturers expanding their rapid test portfolio into new clinical markets.
Add a proven, brandable reader platform to your assay portfolio without the cost and timeline of in-house hardware development. Detekt’s OEM program gives you a validated, clinically-ready platform with full regulatory documentation support — so your team stays focused on the assay, not the instrument.
Support companion diagnostics, clinical trial biomarker monitoring, or decentralized care programs with validated, configurable reader hardware. Detekt’s platforms are built for the clinical environments your programs operate in — from hospital-based testing to patient self-testing in the home setting.
Skip the cost and timeline of in-house hardware R&D and launch with a field-proven, regulatory-ready platform. Detekt’s OEM program is structured to support early-stage companies from initial assay validation through first commercial deployment — with the flexibility to scale to custom hardware as your program and volume grow.
Our OEM process is designed to move efficiently from initial discussions to a field-ready, branded product.
Understand your program requirements, timeline, and volume expectations.
Select hardware platform, customization scope, and receive a detailed proposal.
Custom branding, firmware configuration, and assay validation with your team.
Scaled manufacturing from our US facility with ongoing support and supply.
Let’s talk OEM partnership, white label, or custom platform development.
Ask us any questions about your test kit or results.