Key Devices

[Elwanda Menhennett]

Leveragingproprietary bioprocess technology to produce reliable and predictive organoids at scale to innovating the cell culture system of the future, we believe in the revolutionary promise of 3D biology.

And, with the recent launch of CloneSelect Imager FL with multi-channel fluorescence for day zero monoclonality verification and confirmation of CRISPR edits, provides a wide range of cell and gene therapy applications.

From our PhD-level technical support staff to our expert-trained and certified field service engineers, we guide scientists through customized automation solutions that are uniquely designed to meet the specific needs of their assay, method, or protocol.

A leader in comprehensive GxP compliance solutions, we combine our SpectraMax microplate readers, SoftMax Pro GxP software, SpectraTest Validation Plates and expert IQ/OQ/PM services to help laboratories operating under GMP and GLP regulations follow FDA or regional regulatory guidelines with confidence.

Explore our fully-integrated, automated workflow solutions for cell and biochemical assays. Our scalable ELISA Workcells provide walkaway time, increasing throughput, effectiveness and efficiency of the assay procedure, and reproducibility.

An Al-driven cell culture innovation hub, the CellXpress.ai system automates processes, improves workflows, and makes assays more reliable and reproducible with machine learning-assisted monitoring, feeding, imaging and scheduling.

Quality-controlled organoids are manufactured at scale for high-throughput screening, leveraging proprietary bioreactor and bioprocess technology to produce reliable and predictive patient-derived organoids (PDOs).

Out-of-the-box integration of the enhanced BAB400 with the ImageXpress Confocal HT.ai High-Content Imaging System and IN Carta Image Analysis Software for an optimized end-to-end workflow solution for your 3D biology research.

Ranging from automated digital microscopy to high-throughput confocal imaging systems with water immersion objectives, proprietary spinning disk technology, 7-channel laser light source, and machine-learning software analysis workflow.

The QPix 400 Microbial Colony Picker, ClonePix 2 Mammalian Colony Picker, and CloneSelect FL Imager increase throughput and consistency across cell line development, monoclonal antibody discovery, and synthetic biology workflows.

Fully-integrated, lab automation solution for molecular cloning, antibody discovery, and monoclonality. Our automated clone screening workflows integrate laboratory devices to increase your throughput and efficiency while reducing human interaction.

A fully automated platform designed for researchers aiming to streamline their plasmid preparation process. From transformation to plasmid purification, achieve low to medium throughput with validated protocols, all in an entry-level automation setup with the potential to expand.

In the midst of an evolving drug discovery paradigm, researchers worldwide are transitioning their compound screens away from 2D cell cultures and animal models to more complex, human-relevant 3D systems like organoids. Experience our interactive infographic as it takes you deeper into why the industry is embracing this next generation of drug discovery and the innovations supporting scientists in their 3D biology journey.

With our automated 3D cell culture and bioimaging screening solutions, we are helping reshape the future of drug discovery. Supported by our technology and organoid development protocols, researchers can now advance and scale screening methods for physiologically-relevant 3D models that more closely mimic patient disease states and human organs, leading to faster drug development and approval.

A critical step in the drug discovery process, drug screening and toxicity assessment uncover the effects of potentially life-saving compounds. Shifting to cell-based testing allows multiple chemicals to be tested rapidly and better represents human biology.

We will repair or replace any defective device for the life of EarthQuaker Devices\u2122 but we do not accept returns for any reason. That said, most of our Dealers have excellent return policies. Some will even accept devices that were purchased from a third party. If you are unsure about an item, please buy from a Dealer.

EarthQuaker Devices will never share your private information, including your address, email or phone number, with any third party, ever. We will only use your information to complete and communicate with you regarding your order. If you sign up for our news and updates through Mailchimp, we will only use your email to send you information about EarthQuaker Devices and directly related info.

The first release of sign design details for new signs in the 11th Edition of the MUTCD are now available on the Standard Highway Signs publication webpage. Specifically, this release includes sign design details for the new warning signs. In addition to the sign design details, supporting vector graphics are also included in multiple formats. Additional phased releases will be posted periodically as the new sign design details become available, ultimately resulting in a completely new edition of the Standard Highway Signs publication.

The MUTCD, which has been administered by the FHWA since 1971, is a compilation of national standards for all traffic control devices, including road markings, highway signs, and traffic signals. It is updated periodically to accommodate the nation's changing transportation needs and address new safety technologies, traffic control tools, and traffic management techniques.

On December 19, 2023, a Final Rule adopting the 11th Edition of the MUTCD was published in the Federal Register with an effective date of January 18, 2024. States must adopt the 11th Edition of the National MUTCD as their legal State standard for traffic control devices within two years from the effective date. The Federal Register notice, which provides detailed discussion of the final dispositions of major changes from the 2009 edition, can be viewed at -27178.

You can see computers, phones, and other devices where you are or were signed in to your Google Account recently. You can check google.com/devices to make sure no one else has signed in to your account.

Many internet, cable, and pay TV providers include the Netflix app on their devices. To get started, search the name of your provider in our Help Center to check if Netflix is available on your device. To learn more about device support, contact us or the company that provided your device.

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The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.

The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.

Devices subject to premarket approval applications (PMAs), premarket notification [510(k)], or requests for De Novo classification request are eligible for Breakthrough Device designation if the device meets both of the following criteria:

You can send a Breakthrough designation request for your device at any time before sending your marketing submission (for example, premarket approval [PMA], premarket notification [510(k)], or De Novo classification request).

You can request Breakthrough Device designation by submitting a "Designation Request for Breakthrough Device" Q-Submission. Your designation request should be the only request in the Q-Submission. If you are pursuing the Breakthrough Device designation while you have other requests for feedback pending, you may want to send the requests for feedback after the FDA makes a designation decision, because the designation may affect the feedback that the FDA provides on your other requests. The procedures for submitting a Q-Submission are outlined in the guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request.

It is helpful when you are available and responsive to the FDA's requests throughout the review timeline. If the FDA does not receive the needed information to decide on a designation request promptly, it may result in denial of the Breakthrough Device designation request.

If your device is not eligible for a Breakthrough Device designation because it is not intended for the treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, you may consider whether or not your device would be a candidate for the Safer Technologies Program.

Before issuing a marketing authorization, the FDA generally cannot publicly disclose whether a sponsor has submitted a Breakthrough Device designation request for a device or whether the FDA has granted or denied the request, unless the sponsor decides to make that information available to the public.

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