FDA.reportPublic FDA data

MedMira Rapid H. Pylori Antibody Test

Primary DI
00628451188278
Brand
MedMira Rapid H. Pylori Antibody Test
Company
MedMira Laboratories Inc
Model
815311003820
Device description
The MedMira Rapid H. Pylori Antibody Test is a rapid flow through test developed and manufactured by MedMira Laboratories Inc.
Published
2024-07-09
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
K002023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002023000MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714Medmira Laboratories, Inc.2000-11-13LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628451188278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451188278006284511882786284511882780628451188278

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
902-450-1588support@medmira.com

Regulatory Flags#

DUNS number
243757049
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10628451188213HIV-1/2 Antibody Test Controls8153110075452024-04-11
10628451188220Reveal G4 Rapid HIV-1/2 Antibody Test8153110075522024-04-11
10628451188237Reveal G4 Rapid HIV-1/2 Antibody Test8153110075692024-04-11
10628451188244Reveal G4 Rapid HIV-1/2 Antibody Test8153110075382024-04-11
10628451188251HIV-1/2 Antibody Test Controls8153110075212024-04-11
10628451188268HIV-1/2 Antibody Test Controls8153110075142024-04-11
10628451188169Reveal G4 Rapid HIV-1/2 Antibody Test8152110075072024-04-08
10628451188114Reveal G4 Rapid HIV-1 Antibody Test8153110075522016-01-19
00628451188186Reveal G4 Rapid HIV-1/2 Antibody Test8153110075762024-04-11
00628451188193Reveal G4 Rapid HIV-1/2 Antibody Test8153110005912024-04-11
00628451188209HIV-1/2 Antibody Test Controls8153110075902024-04-11
00628451188179Reveal G4 Rapid HIV-1/2 Antibody Test8153110075832024-04-10
10628451188107HIV-1 Antibody Test Controls8153110075452016-01-19
10628451188121Reveal G4 Rapid HIV-1 Antibody Test8153110075692016-01-19
10628451188138Reveal G4 Rapid HIV-1 Antibody Test8153110075382016-01-19
10628451188145HIV-1 Antibody Test Controls8153110075212017-12-12
10628451188152HIV-1 Antibody Test Controls8153110075142018-02-12
00628451188049MedMira Universal Buffer1009785RDB-G31009785RDB-G32015-05-31
00628451188056Reveal G4 Rapid HIV-1 Antibody Test8153110075832016-04-30
00628451188063Reveal G4 Rapid HIV-1 Antibody Test8153110075762016-01-19

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
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
00840733101670PREMIER Platinum HpSA PLUSMERIDIAN BIOSCIENCE, INC.LYR2020-08-11