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Faq

ShapeFrequently Asked Questions

Get Every Single Answer There If You Want

Our clinic is strategically located for easy access, ensuring that you can reach us conveniently from various parts of the community. We also provide accessibility.

We offer a combination of FDA-cleared, EUA-listed, and LDT-validated assays. Our long-term roadmap includes full FDA 510(k) registration and manufacturing alignment with regulatory requirements in the U.S.

Med X Diagnostics LLC holds CLIA, COLA, NPI, and LTD-based accreditations. Our upcoming Batavia, IL manufacturing facility is being designed to meet FDA, CDC, and ISO 13485 compliance.

Our portfolio includes:

  • Molecular assay panels (PCR-based)

  • Rapid tests (COVID, Influenza, UTI, STI)

  • Lab instruments (PCR systems, extractors)

  • Custom reagents & specimen transport kits

Our U.S.-based team co-engineers assay formulas with Bioteke. After validation and QC review, reagents are packaged and labeled at our Batavia facility under GMP conditions using temperature-monitored workflows.

We maintain strict storage conditions:

  • Molecular reagents: 2°C–8°C

  • Rapid tests: 15°C–30°C

  • Instruments: Humidity and shock-protected storage
    Our facility uses digital monitoring and alarm alerts for any temperature deviation.

We follow FDA labeling guidelines and provide private-label branding for distributors. Each kit includes barcoded tracking, instructions, expiration details, and lot documentation to support CLIA-lab onboarding.

Yes, we offer white-label and custom packaging services tailored to CLIA labs, hospital systems, and international buyers. Customization includes branding, inserts, and multilingual instructions.

We ship nationwide and to Canada/Mexico with:

  • Cold-chain or ambient logistics

  • Express and freight shipping options

  • Tracking, QC checklist, and shipment log included

Yes. Our team has tested over 100 patients during assay engineering. We provide complete validation data including sensitivity, specificity, LoD (limit of detection), and clinical sample reports upon request.

Yes. Our 18,000 sq. ft. industrial facility in Batavia, Illinois is under construction. It will be used for reagent manufacturing, packaging, warehousing, and fulfillment — reducing overseas dependency.

We currently serve the entire United States and are actively expanding to Canada and Mexico. Our goal is to provide fast, compliant diagnostic products across North America.

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