Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA BRTKCALC

GUDID 00840733101458

The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.

MERIDIAN BIOSCIENCE, INC.

Helicobacter pylori urease IVD, kit, chromogenic
Primary Device ID00840733101458
NIH Device Record Key3475f7ef-0fa5-4337-8583-51e04102b3b3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
Version Model Number2.0
Catalog NumberBRTKCALC
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 Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101458 [Primary]

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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