Quality Policy:

 “Quality is our way of life to improve your way of life”

People – Our people are committed to continuously improving our products, processes, and Quality Management System to create safe and effective medical devices that meet the needs of our end users.

Customers – We obsess over our customers, and they deserve the highest quality products possible. Cairn commits to using state of the art processes and technologies to provide innovative solutions to help diagnose gastroparesis.

Community – We are continuously working to improve our community, bringing convenient, fast, and accurate medical devices to market to help others.

GEBT TEST SUMMARY AND APPROVALS

FDA APPROVALS AND REGISTRATIONS
Intended Use The Gastric Emptying Breath Test (GEBT), to be used with the GEBT test meal, is intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
FDA Pre-Market Approvals (PMA’s) GEBT Device Approval: PMA 110015 13C-Spirulina Gastric Emptying Breath Test -GEBT: 04/06/2015 – Cairn Diagnostics

 

GEBT Approval for Telehealth Administration: PMA 110015 S008 – 13C-Spirulina Gastric Emptying Breath Test – Administration by Telehealth:  08/10/2021 – Cairn Diagnostics
Establishment Registration(s) Establishment Name Registration Number Current Registration Year
CAIRN DIAGNOSTICS  TN/US – Headquarters (+ Diagnostic Kit Manufacturing and CLIA Lab) 3010031043 2024
CAIRN DIAGNOSTICS TN/USA- 13C-stable isotope Spirulina Production Facility 3011592854 2024
 
ISO13485:2016 CERTIFICATION
Brentwood, TN – Headquarters

Franklin, TN – API Production Facility

 Facility Certification – MD 774728

Facility Certification – MD 774728

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