FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380163576
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
1077-25EIA
Catalog number
1077-25EIA
Device description
H. pylori Stool Antigen ELISA Kit
Published
2019-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYRHelicobacter pylori

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYRHelicobacter PyloriMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053335000PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480Meridian Bioscience, Inc.2006-03-10LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380163576PrimaryGS10
10885380163579Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538016357620885380163576
1088538016357910885380163579

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
96
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

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
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