Otsuka America Pharmaceutical Inc

Address:3956 Point Eden Way,Hayward,CA,94545,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Test, Urea Adult And Pediatric (Breath), (OZA) (4) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (2)

Premarket Exempt

No Yes

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BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) - 00857335005008 Catalog Number :

Device Description : 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.

Device Class :

Duns Number: 008314390

Premarket Exempt : No

Product Code : OZA

Prescription Use : Yes

Device Count : 1

Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - 00857335005015 Catalog Number :

Device Description : 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.

Device Class : 3

Duns Number: 008314390

Premarket Exempt : No

Product Code : OZA

Prescription Use : Yes

Device Count : 1

BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) - 00857335005039 Catalog Number :

Device Description : This is the Metabolic Solutions Kit version of the kit.

Device Class :

Duns Number: 008314390

Premarket Exempt : No

Product Code : OZA

Prescription Use : Yes

Device Count : 1

MyCite Patch - 00857335005053 Catalog Number :

Device Description : DW5 replacement patch

Device Class : 2

Duns Number: 008314390

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - 00857335005077 Catalog Number :

Device Class : 3

Duns Number: 008314390

Premarket Exempt : No

Product Code : OZA

Prescription Use : Yes

Device Count : 1

MyCite Patch - 00857335005091 Catalog Number :

Device Description : 2 component patch RW2

Device Class : 2

Duns Number: 008314390

Premarket Exempt : Yes

Product Code : DXH

Prescription Use : Yes

Device Count : 1

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