FDA.report

Henry Schein

Primary DI
00304040155745
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LYRHelicobacter pylori

Product Code Classifications

CodeDeviceSpecialtyClass
LYRHelicobacter PyloriMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040155742PrimaryGS10
00304040155745Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404015574210304040155742
00304040155745003040401557453040401557450304040155745

GMDN Terms

TermDefinition
Helicobacter pylori antigen IVD, kit, immunochromatographic test (ICT), rapidA 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. This test is commonly used in the laboratory or in point-of-care analyses for detecting 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187487Zirlux920004892000482026-02-04
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00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10673486013986Teco Diagnostics H. Pylori Card TestTECO DIAGNOSTICSLYR2026-01-27
00816576027439 QwikIDHARDY DIAGNOSTICSLYR2025-06-23
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
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
00612479261488McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261518McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
10885380183645CARDINAL HEALTHCardinal Health 200, LLCLYR2022-02-23
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
00840733101779ImmunoCard H. pyloriMERIDIAN BIOSCIENCE, INC.LYR2020-08-11
00083059070040GAP®-IgG (Gastritis and Peptic Ulcer Test)BIOMERICA, INC.LYR2020-07-01
00840733101427Curian AnalyzerMERIDIAN BIOSCIENCE, INC.LYR2020-05-14
00840733102271Curian HpSAMERIDIAN BIOSCIENCE, INC.LYR2020-05-14
00612479240070McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2020-03-13
00612479240087McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2020-03-13
05391516747516Trinity BiotechCLARK LABORATORIES, INC.LYR2019-11-05
00857031002622QuickVue TLI H. pylori Stool Antigen TestTECHLAB, INC.LYR2019-09-26
00350770926636AVANOSAvanos Medical, Inc.LYR2019-07-24
00350770927459AVANOSAvanos Medical, Inc.LYR2019-07-24