FDA.reportPublic FDA data

QuickVue TLI H. pylori Test

Primary DI
00857031002561
Brand
QuickVue TLI H. pylori Test
Company
TECHLAB, INC.
Model
20343
Device description
The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
Published
2019-05-30
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181379000H. PYLORI QUIK CHEKTechlab, Inc.2018-08-21LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002561008570310025618570310025610857031002561

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori antigen 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 antigens from Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614218634
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857031002547TRI-COMBO PARASITE SCREENT50322019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETET50382019-05-31
00857031002073C. DIFFICILE TOX-B TEST30399U2020-01-24
00857031002530LEUKO EZ VUET50192020-01-24
00857031002226C. DIFF CHEK - 60T50252019-04-12
00857031002455CAMPYLOBACTER QUIK CHEKT50472019-04-12
00857031002301CRYPTOSPORIDIUM IIPT50142016-08-23
00857031002523H. PYLORI CHEK309962018-09-28
00857031002356LACTOFERRIN EZ VUET50182019-05-31
00857031002585QuickVue TLI Lactoferrin Test203452019-05-30
00857031002189LACTOFERRIN EZ VUE303532019-05-29
00857031002172LEUKO EZ VUET303552019-04-12
00857031002646C. DIFFICILE TOX A/B IIT5015XB2021-05-07
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITT50002020-01-24
00857031002264C. DIFFICILE TOX-B TESTT50032020-01-24
00857031002622QuickVue TLI H. pylori Stool Antigen Test203432019-09-26
00857031002196SHIGA TOXIN QUIK CHEKT306252019-08-06
00857031002417SHIGA TOXIN CHEKT306962019-08-06

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