IMPROVE H. pylori Drug Resistance Gene Detection Kit

A real-time PCR drug resistance detection kit grouped under the category Solution for LDT, designed for GI tumor analysis .

Qty: 48 tests/box / Real-time PCR Format

For Research Use Only

Certification: ISO13485

Warranty Policy

LIMITED WARRANTY — RESEARCH USE ONLY (RUO) DISPOSABLE CONSUMABLES

0. Intended Use Notice
This product is labeled and sold strictly for Research Use Only (RUO). It is not intended, labeled, or authorized for use in the diagnosis, treatment, prevention, or clinical management of any disease or condition in humans or animals. It has not been submitted for, and does not require, 510(k) clearance, PMA approval, or equivalent regulatory clearance. This warranty applies solely to the product's condition and manufacturing quality as delivered for research, laboratory, or non-clinical investigational use.

1. Warranty Provider and Scope
The warranty is provided and conducted strictly by the manufacturer of this particular product, not by Medaza,Inc. The manufacturer warrants to the original purchasing entity ("Buyer") that, at the time of shipment, this disposable consumable product is free from defects in materials and workmanship, and conforms to its published specifications, provided the product's original packaging and sterile barrier (if applicable) remain unopened and intact.

Because this product is a single-use, disposable item, this warranty is strictly limited to manufacturing and packaging defects discovered prior to use and does not constitute a general performance, durability, or time-based warranty. Once a unit's packaging has been opened or the unit has been used, it is no longer eligible for warranty claim, regardless of remaining inventory age.

2. Claim Window
A warranty claim must be submitted within thirty (30) days of receipt of the shipment, or before the product's labeled expiration date, whichever is earlier. Claims submitted outside this window will not be honored.

3. Depot/Reporting-Only Return Procedure
Warranty service for disposable consumables is handled as a reporting and credit/replacement process, not a repair process.

• First Step (Intake): The Buyer must not contact the manufacturer directly. The Buyer must contact Medaza,Inc first by email at contactusa@medaza-platform.com, including lot number, quantity affected, photos of the defect and packaging, and date of receipt.
• Delegation: Medaza, Inc. will coordinate with the manufacturer to validate the claim and determine whether replacement, credit, or return is appropriate. If a physical return is required for manufacturer inspection, Medaza, Inc. will secure a Return Merchandise Authorization (RMA) number before any shipment is accepted.
• No Unauthorized Returns: No shipments will be accepted by the manufacturer's facility without an active, authorized RMA number.

4. Allocation of Shipping Costs
For validated manufacturing-defect claims, the manufacturer will cover reasonable inbound and outbound shipping costs for the affected units. For claims found not to be a manufacturing defect (see Section 6), the Buyer is responsible for all associated shipping costs.

5. Universal Recall & Systemic Defect Exception
If the affected lot is officially determined by the manufacturer, Medaza, Inc., or an authorized regulatory or safety body to be subject to a Universal Recall, Safety Alert, or a verified batch-wide Systemic Manufacturing Defect, the manufacturer will cover full replacement and standard two-way ground shipping costs for all affected units, regardless of the 30-day claim window in Section 2.

6. Warranty Exclusions
This warranty does not cover:

• Any unit where the original packaging or sterile barrier has been opened, breached, or tampered with.
• Damage caused by improper storage (including temperature/humidity excursions outside labeled conditions), accident, abuse, liquid exposure, neglect, or improper handling by the Buyer.
• Products used past their labeled expiration date.
• Normal variability in disposable consumables that falls within published specification tolerances.
• Any use of the product outside of research, laboratory, or non-clinical investigational settings, including any off-label clinical, diagnostic, or therapeutic use.
• Indirect, incidental, or consequential costs arising from use of a defective unit (e.g., cost of repeated research runs, lost data, or lost research time).

7. Disclaimer of Clinical Warranties
Because this product is designated Research Use Only, no warranty — express or implied — is made regarding its accuracy, reliability, sterility for clinical use, or fitness for any clinical, diagnostic, therapeutic, or regulated medical use. Buyer assumes full responsibility for determining the product's suitability for its intended research application and for compliance with all applicable institutional, state, and federal research-use regulations.