FDA.reportPublic FDA data

PyloPlus+ Urea Breath Test Analyzer

Primary DI
00860001810363
Brand
PyloPlus+ Urea Breath Test Analyzer
Company
Arj Medical, Inc.
Model
PPUBTA-02
Published
2025-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P170022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170022000PyloPlus UBT SystemArj Medical, Inc.2020-02-18OZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001810363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001810363008600018103638600018103630860001810363

GMDN Terms#

Term, Definition table
TermDefinition
Infrared spectrometry breath analyser IVDAn electrically-powered laboratory or point-of-care instrument designed to use infrared spectrometry technology for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is typically used to measure analytes such as ingested carbon isotopes that have been metabolized (e.g., 13C, 14C) to establish a correlation with metabolic profiles or disorders [e.g., gastrointestinal H. pylori infection]. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006808397
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001810394PyloPlus+ Rapid Urease TestPYLO-502025-01-29
00860001810325PyloPlus+ Urea Breath Test KitPPUBTK2025-01-20
00860001810370PyloPlus+ Urea Breath Test Pro AnalyzerPPUBTA-162025-01-20
00860001810387PyloPlus+ Urea Breath Test Lab AnalyzerPPUBTLA-042025-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001810325PyloPlus+ Urea Breath Test KitArj 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
00840733101458Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CAMERIDIAN 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