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 00857335005053 DW5 DW5 replacement patch DXH Transmitters And Receivers, Electrocardiograph, Telephone 2 MyCite Patch
Other products with the same Product Code "OZA"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization 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. Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA OTSUKA AMERICA PHARMACEUTICAL INC
2 00857335005039 01M This is the Metabolic Solutions Kit version of the kit. BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) OTSUKA AMERICA PHARMACEUTICAL INC
3 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. Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA OTSUKA AMERICA PHARMACEUTICAL INC
4 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. BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) OTSUKA AMERICA PHARMACEUTICAL INC
5 00840733101458 2.0 BRTKCALC The web based application for calculation pediatric urea hydrolysis rate as part The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori. Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA MERIDIAN BIOSCIENCE, INC.
6 00840733101434 01 8209 The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in t 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 is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration 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 the heath care professional, as ordered by a licensed health care practitioner. BreathTek UBT for H. pylori MERIDIAN BIOSCIENCE, INC.