FDA.reportPublic FDA data

Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

Primary DI
00840733101458
Brand
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
Company
MERIDIAN BIOSCIENCE, INC.
Model
2.0
Catalog number
BRTKCALC
Device description
The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
Published
2022-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZATest, Urea Adult And Pediatric (Breath),

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZATest, Urea Adult And Pediatric (Breath),Microbiology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100025000BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0Meridian Bioscience, Inc.2012-02-22OZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101458008407331014588407331014580840733101458

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori urease IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001810325PyloPlus+ Urea Breath Test KitArj Medical, Inc.OZA2025-01-20
00860001810363PyloPlus+ Urea Breath Test AnalyzerArj Medical, Inc.OZA2025-01-20
00860001810370PyloPlus+ Urea Breath Test Pro AnalyzerArj Medical, Inc.OZA2025-01-20
00860001810387PyloPlus+ Urea Breath Test Lab AnalyzerArj Medical, Inc.OZA2025-01-20
00840733101434BreathTek UBT for H. pylori MERIDIAN BIOSCIENCE, INC.OZA2022-02-11
00857335005008BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) Otsuka America Pharmaceutical IncOZA2017-05-16
00857335005039BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)Otsuka America Pharmaceutical IncOZA2017-05-16
00857335005077Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CAOtsuka America Pharmaceutical IncOZA2017-04-19
00857335005015Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CAOtsuka America Pharmaceutical IncOZA2014-09-23