Terms of Service

1. Acceptance of Terms

These Terms of Service (the “Terms”) govern your access to and use of aletradiagnostics.com (the “Website”) and the purchase of products through Altera Diagnostics (“Altera,” “we,” “us”). By accessing the Website or submitting an order, you agree to be bound by these Terms. If you do not agree, please do not use the Website.

2. Intended Audience & Eligibility

The Website and the products described are intended solely for licensed healthcare professionals and authorized purchasing agents of healthcare facilities in the United States. FebriDx is an FDA-cleared, CLIA-waived in vitro diagnostic device available by prescription only (Rx-only) under 21 CFR 801.109. By submitting an order, you represent and warrant that you are at least 18 years old and authorized to purchase prescription medical devices on behalf of a qualified facility.

3. Products & Distributor Role

FebriDx^®is manufactured by the device’s OEM; Altera Diagnostics is an authorized U.S. distributor and does notdesign, manufacture, label, or control the labeling of the product. The manufacturer’s Instructions for Use (IFU), package insert, and limited warranty govern product performance. Product availability, specifications, and pricing are subject to change without notice.

4. Intended Use & Labeling

FebriDx is indicated for use in patients aged 12 to 64 who present to urgent care or emergency care settings for evaluation of acute respiratory infection with symptoms for less than 7 days and within 3 days of fever onset. Test results are intended to be used in conjunction with other clinical and diagnostic findings and should not be the sole basis for treatment decisions. The product must be used strictly in accordance with its FDA-cleared labeling and IFU.

5. Off-Label Use Disclaimer

Any use of the product outside its cleared indications, IFU, or package insert is considered off-label and is at the user’s sole risk. Off-label use voids all warranties, express or implied, and Altera Diagnostics disclaims all liability arising from off-label use.

6. Medical Disclaimer

Content on this Website is provided for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. No physician-patient relationship is created by your use of this Website. Always rely on the manufacturer’s labeling, your clinical judgment, and applicable standards of care when using the product.

7. Ordering, Pricing & Payment

Order requests submitted through our Website are not binding purchase agreements until accepted in writing by an Altera Diagnostics representative, who will verify pricing, eligibility, availability, and delivery terms. Pricing displayed on the Website is subject to change and may vary by volume, account terms, and contract pricing. You are responsible for applicable sales, use, and excise taxes, and for any customs or import duties where relevant.

8. Shipping, Title & Risk of Loss

Unless otherwise agreed in writing, shipments are F.O.B. origin: title and risk of loss pass to purchaser upon delivery to the carrier. Delivery dates are estimates only. Altera Diagnostics is not liable for delays caused by carriers, suppliers, or events outside our reasonable control.

9. Returns, Cancellations & Recalls

In vitro diagnostic products are generally non-returnable once opened or temperature-excursion has occurred. Unopened product in original packaging may be returned within 30 days of delivery subject to a restocking fee; shipping or handling errors will be corrected without charge. In the event of a product recall or field-safety action, you agree to cooperate with Altera Diagnostics and the manufacturer in locating, segregating, and returning affected product.

10. Warranty Disclaimer

Except for the manufacturer’s written limited warranty that accompanies the product, the product and the website are provided “as is” and “as available.” Altera Diagnostics disclaims all warranties, express or implied, including the implied warranties of merchantability, fitness for a particular purpose, title, and non-infringement. Altera Diagnostics does not warrant that the website will be uninterrupted, error-free, or free of viruses or other harmful components.

11. Limitation of Liability

To the fullest extent permitted by law, Altera Diagnostics’ aggregate liability arising out of or relating to the website or any product shall not exceed the amounts paid by purchaser for the product(s) giving rise to the claim in the twelve (12) months preceding the event. Altera Diagnostics shall not be liable for indirect, incidental, special, consequential, or punitive damages, including lost profits, business interruption, or loss of data, even if advised of the possibility of such damages.

Nothing in these Terms limits liability that cannot be limited under applicable law, including for death or bodily injury caused by gross negligence or willful misconduct.

12. Indemnification

You agree to defend, indemnify, and hold harmless Altera Diagnostics, its officers, employees, and agents from and against any claims, damages, liabilities, and expenses (including reasonable attorneys’ fees) arising out of (a) your use of the Website or product in violation of these Terms or applicable law, (b) off-label use, (c) your independent HIPAA, CLIA, or state-law obligations, or (d) your representations regarding eligibility to purchase prescription medical devices.

13. HIPAA & CLIA Responsibility

Altera Diagnostics is not a HIPAA covered entity or business associate and does not receive Protected Health Information through the Website. Purchasers are solely responsible for compliance with HIPAA, CLIA, state laboratory laws, and all other regulatory requirements applicable to their clinical operations.

14. Intellectual Property

FebriDx^® is a registered trademark of its manufacturer. All content on this Website — including text, graphics, logos, images, video, and software — is the property of Altera Diagnostics or its licensors and is protected by copyright and trademark laws. You may not reproduce, distribute, modify, or create derivative works without prior written consent, except for internal reference use by authorized healthcare professionals.

15. Third-Party Links

The Website may contain links to third-party websites, including clinical publications, manufacturer resources, and partner sites. These links are provided for convenience only. Altera Diagnostics does not endorse and is not responsible for the content, policies, or practices of third-party sites.

16. Electronic Communications

You consent to receive electronic communications from us (including order confirmations, service notices, and legal disclosures) and agree that electronic signatures, contracts, and records satisfy any legal requirement that such communications be in writing, under the E-SIGN Act and applicable state UETA.

17. Export Controls

You may not purchase, export, or re-export the product, directly or indirectly, to any country, entity, or person subject to U.S. economic sanctions or export controls, or use the product for any purpose prohibited by U.S. law.

18. Dispute Resolution

Before initiating formal proceedings, the parties shall attempt in good faith to resolve any dispute through informal written notice and a 30-day negotiation period. If unresolved, the exclusive venue for any action shall be the state or federal courts located in King County, Washington, and each party irrevocably consents to personal jurisdiction and venue there.

Each party waives any right to a jury trial. The parties further waive any right to bring or participate in a class, collective, or representative action.

19. Governing Law

These Terms are governed by the laws of the State of Washington, without regard to its conflict-of-law principles. The U.N. Convention on Contracts for the International Sale of Goods does not apply.

20. Miscellaneous

These Terms, together with any order confirmation and the manufacturer’s IFU and warranty, constitute the entire agreement between you and Altera Diagnostics regarding the Website and product purchases. If any provision is held unenforceable, the remaining provisions will remain in full force. Our failure to enforce any right is not a waiver. You may not assign these Terms without our written consent; we may assign them in connection with a merger, acquisition, or sale of assets. Neither party is liable for failure to perform due to causes beyond its reasonable control (force majeure).

21. Changes to These Terms

We may modify these Terms from time to time. Material changes will be posted on this page with an updated revision date, and where required by law we will provide additional notice. Your continued use of the Website or submission of new orders after the effective date constitutes acceptance of the revised Terms.

22. Contact

Questions about these Terms or commercial matters:

Altera Diagnostics
Email: contact@aletradiagnostics.com
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