Quality is our way of life to improve your way of life
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.
THE GEBT SUMMARY AND APPROVALS
Cairn’s ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) measures the rate of ¹³CO2 excretion in breath (kPCD) after consumption of a ¹³C-enriched meal.
| 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 |
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FDA APPROVALS AND REGISTRATIONS |
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| Establishment Registration(s) | Establishment Name | Registration Number | Current Registration Year |
| CAIRN DIAGNOSTICS TN/US – Headquarters (+ Diagnostic Kit Manufacturing and CLIA Lab) | 3010031043 | Establishment Registration & Device Listing | |
| CAIRN DIAGNOSTICS TN/USA- 13C-stable isotope Spirulina Production Facility | 3011592854 | Establishment Registration & Device Listing | |
| ISO13485:2016 CERTIFICATION | |||
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Brentwood, TN – Headquarters Franklin, TN – API Production Facility |
Facility Certification – MD 774728 Facility Certification – MD 774728 |
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