Other products from "OTSUKA AMERICA PHARMACEUTICAL INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857335005077 2.0 The web based application for calculating pediatric urea hydrolysis rate as part The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori. OZA Test, Urea Adult And Pediatric (Breath), 3 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
2 00857335005015 1.1 The web based application for calculating pediatric urea hydrolysis rate as part The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori. OZA Test, Urea Adult And Pediatric (Breath), 3 Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
3 00857335005008 01 The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner. OZA Test, Urea Adult And Pediatric (Breath), BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)
4 00857335005091 RW2 2 component patch RW2 DXH Transmitters And Receivers, Electrocardiograph, Telephone 2 MyCite Patch
5 00857335005039 01M This is the Metabolic Solutions Kit version of the kit. OZA Test, Urea Adult And Pediatric (Breath), BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
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