FDA.reportPublic FDA data

HpOne

Primary DI
00893029002502
Brand
HpOne
Company
GI Supply, Inc.
Model
GIS-64
Catalog number
GIS-64
Device description
HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only.
Published
2021-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYRHelicobacter Pylori

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYRHelicobacter PyloriMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012411000HP-ONEGi Supply2001-09-25LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10893029002509PackageGS150In Commercial Distribution
20893029002506PackageGS120In Commercial Distribution
00893029002502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089302900250910893029002509
2089302900250620893029002506
00893029002502008930290025028930290025020893029002502

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori urease IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-451-5797info@gi-supply.com

Regulatory Flags#

DUNS number
160990313
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893029002595MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
00893029002601MoonPants MLGIS-7-MLGIS-7ML2021-07-20
00893029002618MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
00893029002625MoonPants LongGIS-13GIS-132021-07-20
00893029002632SportShorts XSSL-9XSSL-9XS2021-07-20
00893029002649SportShorts SMSL-9SMSL-9SM2021-07-20
00893029002656SportShorts MLSL-9MLSL-9ML2021-07-20
00893029002663SportShorts XLSL-9XLSL-9XL2021-07-20
00893029002243EverLiftGIS-59GIS-592021-02-18
00893029002229EverLiftGIS-55GIS-552021-02-18
00893029002236RenovaRPGIS-31GIS-312021-07-08
00893029002175RenovaRPGIS-32GIS-322021-07-06
00893029002731RenovaRPGIS-35GIS-352023-12-14
00893029002168RenovaRPGIS-30GIS-302022-08-10
00893029002151RenovaRPGIS-29GIS-292021-07-07
00893029002076RenovaRPGIS-27GIS-272016-09-24
10893029002165RenovaRP Tube SetGIS-30GIS-302022-08-10
10893029002592MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
10893029002608MoonPants MLGIS-7-MLGIS-7ML2021-07-20
10893029002615MoonPants XLGIS-7-XLGIS-7-XL2021-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10763924750044Accutest H. Pylori Urease Rapid Test JANT PHARMACAL CORPORATIONLYR2026-04-21
10673486013986Teco Diagnostics H. Pylori Card TestTECO DIAGNOSTICSLYR2026-01-27
00816576028481 QwikIDHARDY DIAGNOSTICSLYR2025-06-23
00816576027439 QwikIDHARDY DIAGNOSTICSLYR2025-06-23
00860001810394PyloPlus+ Rapid Urease TestArj Medical, Inc.LYR2025-01-29
20888277717777MEDLINEMEDLINE INDUSTRIES, INC.LYR2024-08-08
10888277717770MEDLINEMEDLINE INDUSTRIES, INC.LYR2024-08-08
00628451188278MedMira Rapid H. Pylori Antibody TestMedMira Laboratories IncLYR2024-07-09
00850049545235AccuDiag ™Diagnostic Automation, Inc.LYR2024-05-23
10673486002393Teco Diagnostics H. pylori Card TestTECO DIAGNOSTICSLYR2024-01-16
00083059070835Hp Detect Stool Antigen ELISABIOMERICA, INC.LYR2024-01-08
04048474028157H. Pylori IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLYR2023-08-29
00840733101472Premier HpSA FlexMERIDIAN BIOSCIENCE, INC.LYR2023-08-28
00840239028150H. Pylori IgG ELISA DRG International IncLYR2023-08-24
00612479261471McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261501McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261488McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261518McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00848838022012REMELREMEL, INC.LYR2022-12-22
20885380183642CARDINAL HEALTHCardinal Health 200, LLCLYR2022-02-23
10885380183645CARDINAL HEALTHCardinal Health 200, LLCLYR2022-02-23
10304040155742Henry ScheinHENRY SCHEIN, INC.LYR2021-10-14
00304040155745Henry ScheinHENRY SCHEIN, INC.LYR2021-10-14
10743816001584Status™ H. pylori cardPRINCETON BIOMEDITECH CORPORATIONLYR2021-08-04
10743816001591Status™ H. pylori cardPRINCETON BIOMEDITECH CORPORATIONLYR2021-08-04
00893029002519HpFastGI Supply, Inc.LYR2021-07-08
00893029002571UreaseGI Supply, Inc.LYR2021-07-08
00857031002639H. PYLORI CHEK TECHLAB, INC.LYR2021-03-12
00840733101731PREMIER H. pyloriMERIDIAN BIOSCIENCE, INC.LYR2020-09-01
00840733101670PREMIER Platinum HpSA PLUSMERIDIAN BIOSCIENCE, INC.LYR2020-08-11