FDA.reportPublic FDA data

PyloPlus+ Urea Breath Test Kit

Primary DI
00860001810325
Brand
PyloPlus+ Urea Breath Test Kit
Company
Arj Medical, Inc.
Model
PPUBTK
Published
2025-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00860001810325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001810325008600018103258600018103250860001810325

GMDN Terms#

Term, Definition table
TermDefinition
Carbon isotope breath test kit IVDA collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon isotope-labelled substrate and breath specimen containers or collection card. The test relies on the metabolism of the substrate and expiration of carbon isotopes in CO2. It can be administered by a healthcare professional in a clinical setting or alternatively by the patient at home, for subsequent analysis in a clinical laboratory or at the point-of-care. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006808397
Device count
1
Kit
true
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001810394PyloPlus+ Rapid Urease TestPYLO-502025-01-29
00860001810363PyloPlus+ Urea Breath Test AnalyzerPPUBTA-022025-01-20
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
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
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