InBios International Inc. ReaDX Terms and Conditions
All App Content (as defined below) is current as of the date it is posted on the App to the best of InBios’ knowledge.
- Emergency Use Authorization (“EUA”)
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
- Test Overview and Results
SCoV-2 Ag DetectTM Rapid Self-Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first five days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first five days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test results may be interpreted visually or interpreted digitally by the ReaDX app downloaded onto a compatible device.
The SCoV-2 Ag Detect™ Rapid Self-Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the SCoV-2 Ag Detect™ Rapid Self-Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with a molecular assay, if necessary, for patient management.
For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.
Individuals who test negative and continue to experience COVID-like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider.
Individuals that interpret the test results visually should provide all results obtained with this product to their healthcare provider for public health reporting. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. For individuals that interpret the test results using the ReaDX app, public health reporting of test results may occur via the ReaDX app software application if enabled by the user.
The SCoV-2 Ag Detect™ Rapid Self-Test is intended for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older. The SCoV-2 Ag Detect™ Rapid Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
- Intellectual Property
The App and its entire contents, data, features, and functionality (including but not limited to text, graphics, video, logos, button icons, databases, and images) (“App Content”) are the property of InBios or its licensors and are protected by copyright, trademark and other intellectual property laws, except as indicated below.
The InBios name and related logos are trademarks and service marks (“Marks”) of InBios. InBios Marks may not be used without advance written permission of InBios, including in connection with any product or service that is not provided by InBios, in any manner that is likely to cause confusion, or in any manner that disparages, discredits, or misrepresents InBios. Other products or company names mentioned on the App may be trademarks or service marks of their respective owners.
If you believe that any content on the App violates your intellectual property rights, please notify InBios as described in Section 24.
- Limited License And Prohibited Uses
InBios grants you a personal, royalty-free, non-assignable, revocable, and non-exclusive license to access and use the App Content as an informative resource while using the App. Any other use, including the reproduction, modification, distribution, transmission, republication, framing, display or performance of App Content without prior permission of InBios is strictly prohibited. You may not download, print, copy, distribute, or otherwise use App Content for commercial purposes, including publication, sale, or personal gain. You may not remove any Marks or other proprietary notices, including, without limitation, attribution information, credits, and copyright notices that have been placed on or near the App Content.
- Use the App in any way that violates any applicable law or regulation.
- Use the App for the purpose of exploiting, harming or attempting to exploit or harm anyone in any way.
- Transmit, or procure the sending of, any advertising or promotional material, including any “junk mail,” “chain letter,” “spam,” or any other similar solicitation.
- Impersonate or attempt to impersonate InBios, an InBios employee, another user or any other person or entity (including, without limitation, by using email addresses associated with any of the foregoing).
- Engage in any other conduct that restricts or inhibits anyone’s use or enjoyment of the App, or which, as determined by InBios, may harm InBios or users of the App or expose them to liability.
- Use the App in any manner that could disable, overburden, damage, or impair the App or interfere with any other party’s use of the App, including their ability to engage in real time activities through the App.
- Use any robot, spider or other automatic device, process or means to access the App for any purpose, including monitoring or copying any of the material on the App.
- Use any manual process to monitor or copy any of the material on the App or for any other unauthorized purpose without InBios’ prior written consent.
- Use any device, software or routine that interferes with the proper working of the App.
- Introduce any viruses, Trojan horses, worms, logic bombs or other material that is malicious or technologically harmful.
- Attempt to gain unauthorized access to, interfere with, damage or disrupt any parts of the App, the server on which the App is stored, or any server, computer or database connected to the App.
- Attack the App via a denial-of-service attack or a distributed denial-of-service attack.
- Otherwise attempt to interfere with the proper working of the App.
This App is not intended for children under 14 years of age. InBios does not knowingly collect Information from children under 14 through the App. If you are under 14, do not use this App or provide any Information about yourself to InBios, including your name, address, telephone number or email address.
If you are using the App on behalf of any third party such as a child, elderly individual in your care, other dependent, or a patient in your care, you represent that you have all legal rights to do so and will indemnify InBios if that is not the case.
- Account Registration
To access the App, you will be asked to provide registration details or other Information. It is a condition of your use of the App that all Information you provide is complete, current, and accurate. All Information you provide to register with the App or otherwise is governed by our Privacy Notice, and you consent to all actions InBios takes with respect to your Information consistent with our Privacy Notice.
- Use and Protection of Login Credentials
- Third Party Content
This App may include content provided by third parties. All statements and opinions expressed by third parties are solely the opinions and the responsibility of the person or entity providing those materials. Those materials do not necessarily reflect the opinion of InBios. InBios is not responsible for the content or accuracy of any materials provided by any third parties.
- Links To Other Websites
InBios may provide links to external websites for the convenience of App users. The inclusion of an external link on this App does not constitute or imply support or endorsement of any kind. InBios does not control those websites, is not responsible for their content or function, and is not responsible for any loss or damage that may arise from your use of them. If you decide to access the third party website linked to this App, you do so entirely at your own risk and subject to the terms and conditions of use and the privacy notice for such websites.
- Wireless Access Charges
Certain App functions may require data access, and the provider of data access for your device may charge you data access fees in connection with your use of the App. You are solely responsible for any data access or other charges you incur.
- Payments, Fees, and Other Charges
You are solely responsible for all fees associated with your use of the App if any, including paid plans and those listed within the App itself. You are solely responsible for any and all duties, taxes, levies, or fees (including sales, use, or withholding taxes) imposed by any authority on you by virtue of your transactions through the App.
- Uninstalling the App
Uninstallation methods may vary depending on your device. To uninstall this App, please use the application manager provided with your device or consult your device manual for reference.
- Change or Update to the App; Termination
InBios shall have the right for any reason, in its sole discretion, to terminate, change, suspend or discontinue, temporarily or permanently, any aspect of the App, including but not limited to content or features, without notice to you. We may also impose limits on certain features and services or restrict your access to parts or all of the App with or without notice or liability. From time to time, InBios may make available updates or upgrades to the App via software download or other means. Such download may occur automatically without the need for an act on your part, or it may require you to manually download an update or upgrade through the same source from which the App was originally downloaded. Certain functions of the App may be modified or discontinued as a result of any such update or upgrade, or may not be available if you have not downloaded all updates and upgrades made available by InBios or otherwise.
The App may contain information about InBios or other products or services. The information in the App is accurate as of the date the App is made available for download to you. Such information about InBios or other products or services may be updated from time to time, including without limitation, when the App may be updated or upgraded. You should periodically check whether an updated or upgraded version of the App is available for download.
- Apple App Store
If you download the App from a device made by Apple, Inc. (“Apple”) or from Apple’s App Store, you agree that:
- The license granted to you is limited to a personal, limited, non-exclusive, non-transferable right to install the App on the Apple device(s) authorized by Apple that you own or control for personal, non-commercial use, subject to the usage rules set forth in Apple’s App Store Terms of Services.
- Apple is not responsible for the App or the content thereof and has no obligation whatsoever to furnish any maintenance or support services with respect to the App.
- In the event of any failure of the App to conform to any applicable warranty, you may notify Apple, and Apple will refund the purchase price for the App, if any, to you. To the maximum extent permitted by applicable law, Apple will have no other warranty obligation whatsoever with respect to the App.
- Apple is not responsible for addressing any claims by you or a third party relating to the App or your possession or use of the App, including without limitation (a) product liability claims; (b) any claim that the App fails to conform to any applicable legal or regulatory requirement; and (c) claims arising under consumer protection or similar legislation.
- In the event of any third party claim that the App or your possession and use of the App infringes such third party’s intellectual property rights, Apple is not responsible for the investigation, defense, settlement or discharge of such intellectual property infringement claim.
- You represent and warrant that (a) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country; and (b) you are not listed on any U.S. Government list of prohibited or restricted parties.
- InBios expressly authorizes use of the App by multiple users through the Family Sharing or any similar functionality provided by Apple.
- Disclaimer of Warranties
YOU EXPRESSLY AGREE THAT USE OF THE APP AND CONDUCTING TRANSACTIONS RELATED TO IT ARE AT YOUR SOLE RISK. WHILE INBIOS ATTEMPTS TO PRESENT ACCURATE INFORMATION ON THE APP, THIS APP IS PROVIDED ON AN “AS-IS” BASIS. INBIOS MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, AS TO THE OPERATION OR CONTENT OF THIS APP OR ANY OTHER WEBSITE TO WHICH IT IS LINKED. TO THE EXTENT PERMITTED BY LAW, INBIOS DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR ANY WARRANTIES OF NON-INFRINGEMENT OF ANY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY.
While the app is intended to aid in the performance of rapid tests, no test is 100% ACCURATE, AND INBIOS DOES NOT GUARANTEE THAT THE RESULTS ARE ACCURATE.
As described in the rapid test’s physical labeling, there is a risk of incorrect results when using rapid tests. InBios is not responsible OR LIABLE for damages incurred DUE TO inACCURATE test results or interpretations.
THE INFORMATION AND RESULTS PROVIDED BY THE APP ARE NOT INTENDED TO REPLACE THE GUIDANCE OF A QUALIFIED HEALTHCARE PROVIDER. USERS SHOULD SEEK APPROPRIATE MEDICAL ATTENTION REGARDLESS OF THE DATA PROVIDED BY THE RAPID TEST RESULT AND APP. THE APP DOES NOT PROVIDE TREATMENT ADVICE OR HEALTHCARE SERVICES.
- Limitation of Liability
INBIOS’S MAXIMUM LIABILITY, WHETHER BY STATUTE, IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, PRODUCT LIABILITY, STRICT LIABILITY, OR OTHER THEORY, ARISING OUT OF OR IN CONNECTION WITH YOUR USE OF THE APP OR ITS CONTENT, WILL NOT EXCEED $100.
- Limitation On Time To File Claims
- Injunctive Relief
- Waiver And Severability
- Entire Agreement
- Term and Termination
You agree that InBios, in its sole discretion, may suspend or terminate your access to the App (or any part thereof) for any reason, with or without notice, and without any liability to you or to any third party for any claims, damages, costs or losses resulting therefrom.
- Applicable Law, Binding Arbitration, and Class Action Waiver
PLEASE READ THE FOLLOWING PARAGRAPHS CAREFULLY BECAUSE THEY REQUIRE YOU TO AGREE TO RESOLVE ALL DISPUTES BETWEEN US THROUGH BINDING INDIVIDUAL ARBITRATION.
All claims and disputes within the scope of this arbitration agreement must be arbitrated or litigated on an individual basis and not on a class basis. Claims of more than one customer or user cannot be arbitrated or litigated jointly or consolidated with those of any other customer or user.
- Communications and Contact Information
InBios International, Inc.
307 Westlake Ave. N., Suite 300
Seattle, Washington 98109
EFFECTIVE DATE: March 24, 2022