Mucosal Integrity Conductivity (MI) Test System
by Diversatek Healthcare, Inc.
De Novo DEN180067
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN180067 | Date23 Dec 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA product code
- QIS
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1450
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- DENG De Novo granted
Overview
AI-generated summary, 22 Sep 2026
The Mucosal Integrity Conductivity (MI) Test System is a device used to obtain a real-time measurement of esophageal epithelial impedance during endoscopy. It is indicated for use by gastroenterologists, surgeons, and medically trained personnel to support clinical decision-making in the evaluation of esophageal mucosal integrity.
The system is supplied as a point-of-care testing system for use during endoscopic procedures. It received De Novo classification from the FDA on December 23, 2019, under k-number DEN180067, and is classified as a Class II medical device with product code QIS and regulation number 876.1450.
From the manufacturer
MiVu™ Mucosal Integrity Testing System Join Our Live Webinar on September 22 MiVu™ provides objective, point-of-care data during endoscopy to instantly differentiate GERD, EoE, and Non-GERD and support more informed clinical decision-making.
MiVu™ Mucosal Integrity Testing System MiVu can instantly rule out GERD during index endoscopy, and potentially obviates the need for 24 to 48 hour ambulatory wireless pH monitoring.
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Questions
AI-generated answers, 22 Sep 2026
What is the Mucosal Integrity Conductivity (MI) Test System used for?
The Mucosal Integrity Conductivity (MI) Test System is used to obtain real-time measurements of esophageal epithelial impedance during endoscopy. It supports clinical decision-making by gastroenterologists, surgeons, and medically trained personnel in evaluating esophageal mucosal integrity.
How is the Mucosal Integrity Conductivity (MI) Test System supplied and used?
The system is supplied as a point-of-care testing system designed for use during endoscopic procedures. It is intended to be used by trained medical personnel at the point of care to obtain impedance measurements in real time while performing endoscopy.
Is the Mucosal Integrity Conductivity (MI) Test System a single-use or reusable device?
The device data does not specify whether components of the Mucosal Integrity Conductivity (MI) Test System are single-use or reusable. Therefore, no determination about reusability can be made from the provided information.
What regulatory pathway was used for the Mucosal Integrity Conductivity (MI) Test System?
The Mucosal Integrity Conductivity (MI) Test System received De Novo classification from the FDA on December 23, 2019, under k-number DEN180067, and is classified as a Class II medical device with product code QIS and regulation number 876.1450.