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Support

Technical documentation

Our technical documentation allows you to register your customized system based on our reader very easily. The necessary support you need as private label manufacturer for registration of your product at local authorities in your target countries is given.

We work according to the Quality Management ISO 9001, ISO 13485 Standards and US FDA 21 CFR Part 820.

If you look for additional regulatory advice, DIALUNOX will be happy to assist. Our network of experienced consultants can help you accelarate your submission to the regulatory bodies.

Ongoing trainings & maintenance

As part of our customizing service, we offer

Free remote training helping to optimize your lateral flow reader settings for best interpretation of your test bands
Constant troubleshooting to resolve any technical issues
Product development support from a dedicated Project Manager and a skilled interdisciplinary team
Ongoing maintenance, assistance and information about SW updates
Expert lateral flow development webinars and workshops that provide valuable insights and hands-on orientation

Regulatory advice

If your company does not possess the required know-how in the regulatory field, you are in good hands with DIALUNOX advisory service. Our experienced consultants with both regulatory and scientific background will help you accelerate your submission to IVDR and FDA regulatory bodies ensuring its success and helping identify the right documentation strategy. If need be, they can also serve as a contact point with regulatory authorities and prepare your QM system for audits.

This is what we offer in a nutshell:

Quality management: check and improve your internal processes
Market entry and risk management: create a concept for the market entry of your innovative medical product
Technical documentation: prepare the registration or approval of your medical device in the individual target markets.

Book this service via DIALUNOX and ensure a smooth and fast processes for your submission.

Download the latest software and manuals for your reader.

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Frequently Asked Questions

The DIALUNOX readers are easy-to-use universal measurement tools for lateral flow tests. These devices can be used to perform quality control checks and, if needed, be customized and relabeled with your company name or logo. The customized reader can be then sold together with the rapid test as a test kit.

These can be fluorescence or colorimetric and include any color or from colloidal gold or latex particles. Many different standard configurations are already available and, if necessary, new detectors can also be created.

Its depends on the reader you are interested in. It can be configured for either fluorescence or colometric/reflectometric detection. Both fluorescence and colorimetric detection modes can be combined just in a single ESEQuant LR3 device.

Our starter kit usually contains a universal strip holder and this works with any type of strip. If you need a specific drawer for your own cassette, we can provide a customized part.

Lateral Flow Studio Software is provided as part of the starter kit and this software can be used to configure the reader to analyze any kind of test. The software is very intuitive, but in case of queries, free remote support is offered.

The reader can operate in a stand-alone mode but the method files it uses need to be created using the provided Lateral Flow Studio Software and this needs to be performed on a PC.

Yes, you can create qualitative, semi-quantitative or quantitative methods as well as set thresholds and upload calibration curves.

The method can be added into the reader by either connecting a PC to the reader and then copying and saving the method on the device or by uploading via a 2D barcode.

The device can read from up to 5 different strips and up to 19 different lines per strip with two different channels.

The reproducibility of the measurement has to be determined together with the assay. However, the reader itself has a very low signal variance, with an intra-device coefficent of variance (CV) <3% and an inter-device CV <5%.

The device includes USB ports and ethernet ports. Other interfaces such as a wireless connection are available upon request.

We do not offer assays developed for use with the ESEQuant readers. Our devices are sold to test and quantify assays developed and produced as part of contract manufacturing agreement.

Our Key Account Managers will be happy to answer any questions on rapid testing at the point of need. Please feel free to get in touch with us.

The price strongly depends on the reader you look for. Find out what reader suits you best and contact us for more information.

Depending on what level of customization is needed, it may take as little as 2–4 months to deliver your first customized units.

Any application is feasible and these devices have been customized for use in such fields as human diagnostics (see intended use), veterinary analysis, food and feed safety, biodefense, or environmental testing.

Yes. During the customization process and based on the customer requirements, DIALUNOX will provide you with the required reader documentation and is happy to support you in this process.