FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040155742
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702778
Catalog number
5702778
Device description
Henry Schein One Step + H. Pylori
Published
2021-10-14
Public version status
Update
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
LYRHelicobacter pylori

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYRHelicobacter PyloriMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040155742PrimaryGS10
00304040155745Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404015574210304040155742
00304040155745003040401557453040401557450304040155745

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with H. pylori which is associated with gastroduodenal disorders such as active chronic gastritis and gastric/duodenal ulcers. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
012430880
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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
00304040155745Henry ScheinHENRY SCHEIN, INC.LYR2021-10-14
10743816001584Status™ H. pylori cardPRINCETON BIOMEDITECH CORPORATIONLYR2021-08-04
10743816001591Status™ H. pylori cardPRINCETON BIOMEDITECH CORPORATIONLYR2021-08-04
00893029002502HpOneGI Supply, Inc.LYR2021-07-08
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