Partnering with microbiologists to diagnose and prevent diseaseTM

Services

Services we offer at Hardy Diagnostics

Let Hardy Diagnostics help bring your product to market!

Hardy Diagnostics is an employee owned company with over 40 years of experience in the microbiology culture media industry. Our technical team and regulatory team consist of microbiologists highly experienced in the introduction of diagnostic products into the US market. Our staff has over 30 years of combined industry experience, as well as extensive knowledge and expertise in clinical trials and experience in navigating the FDA’s clearance process.

Comprehensive Product Assessment

  • Microbiology medical devices
  • Consulting services – business intelligence
  • Feasibility analysis

Regulatory Submissions

  • FDA Q-submission
  • 510(k) for class II medical device

Study Design, Planning, & Coordination

  • Drafting study protocols
  • Selection of clinical trial sites
  • Coordination of clinical study
    • Site training
    • Data monitoring and management
    • Data analysis

Analytical Supportive Testing

  • Analytical sensitivity and specificity
  • Cross reactivity studies
  • Limit of detection (LoD)
  • Reproducibility
  • Other

Additional Services

  • Data analysis
  • Technical medical writing
  • Susceptibility profile determination of resistant microorganisms
  • Vast, well-characterized collection of microorganisms available for product evaluations and new antibiotic candidate assessments

About the Team

Our team is made up of professionals with varying backgrounds and years of experience bringing a new perspective to each 510(k) submission. Our team has been instrumental in having over 25 products cleared by the FDA. Part of this experience includes several successful 510(k)s, mainly in antimicrobial resistance detection devices.  Most recently in 2019, NG-Test CARBA 5, a CE marked test available and distributed globally by NG Biotech throughout Europe, was FDA cleared by our team.

Recent Feedback

“Thank you for trusting in NG Biotech from the beginning! We are also grateful to work with Hardy and to bring NG-Test CARBA5 to the USA in cooperation with all of you. It is also a big satisfaction to see that our teams work so well and hard together to make it a success.” – Milovan Stankov-Pugès, NG Biotech, France on 10/9/2019

“It was an absolutely pleasure to work with the team from Hardy on this trial.  I have to say that your team are consummate professionals and are an absolute joy to work with. “– Dr. Nathan Ledeboer, Medical College of Wisconsin, US on 10/11/2019

“Thank you all for your great job and professionalism. I am looking forward to the next steps and our continuous long term partnership.” — Amélie Monnier, NG Biotech, France on 10/3/2019

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Leading Industry Experts

Hardy Diagnostics is an employee owned company with over 40 years of experience in the microbiology culture media industry and manufactures over 2,700 products, including prepared and dehydrated culture media, reagents, automated slide strainers, as well as rapid identification kits. Our customers work in clinical, research, food, water, and pharmaceutical testing laboratories and we understand their needs. Hardy Diagnostics is an FDA licensed in vitro medical device manufacturer and operates under an ISO 13485 certified Quality Management System. Our reputation and expertise in the industry and our commitment to our customers ensures superior service, and high quality, dependable products at competitive prices.

Custom Design

Variations of existing products or development of new products and proprietary formulations. Products manufactured using existing raw materials or raw materials sourced from existing suppliers to provide the best mix of competitive price, superior quality, and short lead time. For proprietary formulations, we offer nondisclosure agreements (NDA) to ensure confidentiality.

Product Evaluation

Hardy Diagnostics offers manufacturing process validation, failure mode analysis, bioburden testing, sterility testing, and testing services using the latest industry tools and standards to perform in-house validations by a team of highly trained, cross-functional Quality Assurance Engineers and microbiologists.

Formulation and Technology Development

Private labeling of custom designs, co-development of new technologies, or large scale contract manufacturing projects.
Products in this category may require extensive project management, statements of work, multi-year manufacturing contracts, new equipment, validations, or development of proprietary new technologies.

Stability Testing

Hardy Diagnostics offers real-time product stability testing. In conjunction with our extensive organism library, we can perform challenge and growth promotion testing to match the intended use
of custom products.

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TrioBasServices

TRIO.BAS Calibration Services

Hardy Diagnostics is the sole North American distributor of the Orum TRIO BAS Microbial Air Samplers. To better service our customers, Hardy Diagnostics now offers complete calibration and repair services for the TRIO BAS air samplers. Register your TRIO.BAS or request calibration and repair services at the links below.

As of 2018, Hardy Diagnostics is an ISO 17025 Certified Facility in the field of Calibration.

QuickSlide Services Page

QuickSlide Automated Slide Instrument Services

QuickSlide by Hardy Diagnostics comprises our line of automated slide staining instruments including the GramPRO 1 automated Gram staining instrument and the HemaPRO automated Wrights-Giemsa slide staining instrument.  Register your instrument or contact the QuickSlide team for instrument repairs at the links below.

Wizardservices

CompactDry Wizard Services

Hardy Diagnostics is proud to introduce our the Wizard CompactDry Reader.  This small colony counting instrument is designed exclusively for the CompactDry line of chromogenic dry media. You can register your Wizard CompactDry Reader at the link below.