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.
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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.
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Community – We are continuously working to improve our community, bringing convenient, fast, and accurate medical devices to market to help others.
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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.
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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.
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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
FDA APPROVALS AND REGISTRATIONS
ISO13485:2016 CERTIFICATION
Brentwood, TN – Headquarters
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Franklin, TN – API Production Facility
Establishment Name
CAIRN DIAGNOSTICS TN/US – Headquarters (+ Diagnostic Kit Manufacturing and CLIA Lab)
CAIRN DIAGNOSTICS TN/USA- 13C-stable isotope Spirulina Production Facility
Establishment Name
3010031043
3011592854
Establishment Registration(s)
Dedicated to your health, every day
The GEBT should not be used in people with hypersensitivity to Spirulina, egg, milk, or wheat allergens and should not be used in patients with certain lung diseases or small bowel malabsorption. For a complete list of warnings, precautions and contraindications, please see the Package Insert.
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