BreathTek UBT for H. pylori 8209

GUDID 00840733101434

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.

Helicobacter pylori urease IVD, kit, chromogenic
Primary Device ID00840733101434
NIH Device Record Key7bbfd703-77b5-41e9-a11b-fe98c3909789
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreathTek UBT for H. pylori
Version Model Number01
Catalog Number8209
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101434 [Primary]
GS100840733101441 [Package]
Package: Kits / Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZATest, Urea Adult And Pediatric (Breath),

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-21
Device Publish Date2022-02-11

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00840733101434 - BreathTek UBT for H. pylori 2022-02-21The 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.
00840733101434 - BreathTek UBT for H. pylori 2022-02-21 The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated wi

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