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In the us the breathid hp system and the breathid hp lab system are intended for use in the qualitative detection of h.
Breathid hp breath test system. In the us the breathid hp system and the breathid hp lab system are intended for use in the qualitative detection of h. Other applications are limited in the us by federal law to investigational use only. Urea breath test ubt with breath hp system breathid hp lab system pediatrics the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Blood chemistry leadcare proficiency and controls human conditions.
The urea breath test is used to detect helicobacter pylori h. Immunoassay curian immunocard stat immunocard premier tru merifluor immunodiffusion latex agglutination quikpac ii genbody. Materials a single breathid idkit hp two is provided to perform the breath test. The exalenz breathid hp lab system consists of the idkit hp two kit and the breathid hp device auto sampler and lab application.
H pylori is a very common bacterium reported to be present in up to two thirds of the world population. The breathid hp breath test system is used to perform a diagnostic test for the presence of helicobacter pylori a bacterium that can cause peptic ulcers and is associated with gastric cancer. If desired use the provided sample transport bag for transport of the breath samples. Pylori a type of bacteria that may infect the stomach and is a main cause of ulcers in both the stomach and duodenum the first.
Other applications are limited in the us by federal law to investigational use only. They have fda 510 k clearance and an approved nda for the 13 c urea tablet and citrica powder. Each idkit hp two for the exalenz breath test with the breathid hp lab system contains. One package insert one tablet of 13c enriched urea 75 mg.
The exalenz breathid hp lab system is indicated for use as an aid in the initial diagnosis and post treatment monitoring of h pylori infection in adult patients and pediatric patients ages 3 17 years old.
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