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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.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution
- 00840733101434 ()
- 00840733101441 ()
8209
- Helicobacter pylori urease IVD, kit, chromogenic
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.
Otsuka America Pharmaceutical Inc
01
In Commercial Distribution
- 00857335005008 ()
- 10857335005029 ()
- Helicobacter pylori urease IVD, kit, chromogenic
Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP112V
In Commercial Distribution
- 05415067034472 ()
LSP112V
- Intracardiac pacemaker
Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP202V
In Commercial Distribution
- 05415067040725 ()
LSP202V
- Intracardiac pacemaker
Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP201A
In Commercial Distribution
- 05415067040701 ()
LSP201A
- Intracardiac pacemaker
Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08348
In Commercial Distribution
- 09008737083489 ()
- Cochlear electrode array depth gauge, single-use
Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08258
In Commercial Distribution
- 09008737082581 ()
- Cochlear electrode array depth gauge, single-use
Insertion Electrode
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08257
In Commercial Distribution
- 09008737082574 ()
- Cochlear electrode array depth gauge, single-use
Single-Use Surgical Tool
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
03875
Not in Commercial Distribution
- 09008737038755 ()
- Surgical implant template, single-use
Insertion Test Device
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
02081
In Commercial Distribution
- 09008737020811 ()
- Cochlear electrode array depth gauge, single-use