FDA.reportPublic FDA data

GAP®-IgG (Gastritis and Peptic Ulcer Test)

Primary DI
08305900070040
Brand
GAP®-IgG (Gastritis and Peptic Ulcer Test)
Company
BIOMERICA, INC.
Model
7004
Device description
The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.
Published
2016-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K915185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915185000GAP IGG H.PYLORI MODIFIEDBiomerica, Inc.1992-03-04LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08305900070040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08305900070040083059000700408305900070040

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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08305900070309Myoglobin Enzyme Immunoassay Test Kit70302016-12-07
08305900070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT70312016-12-08
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]70632016-12-08
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08305900070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]70782016-12-08
08305901048253EZ-hCG Urine Pregnancy Test1048-252016-12-08
08305901501154EZ-GIARDIA One-Step Giardia Test1501-152016-12-08

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