FDA.reportPublic FDA data

Serim® PyloriTek® Test Kit

Primary DI
M1745140K1
Brand
Serim® PyloriTek® Test Kit
Company
SERIM RESEARCH CORPORATION
Model
05140K
Catalog number
05140K
Device description
The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
Published
2016-09-19
Public version status
Update
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
K953632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953632000SERIM PYLORITEK TEST KITSerim Research Corp.1995-12-18LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M1745140D2PackageHIBCC1Not in Commercial Distribution
M1745140K2PackageHIBCC1In Commercial Distribution
M1745140K1PrimaryHIBCC0
M1745140K0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori urease IVD, kit, chromogenicA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius7 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-542-4670customerservice@serim.com

Regulatory Flags#

DUNS number
605151018
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M17452120Serim® GUARDIAN™ Quick Dip Residual Chlorine Test Strips 521252122026-03-30
M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips 510551052016-09-08
M17451091Serim® GUARDIAN™ HiSENSE™ Test Kit 510951092016-09-19
M1745119C1Serim® GUARDIAN™ Blood Leak Test Strips5119C5119C2017-02-12
M17451211Serim® DISINTEK™ OPA Test Strips 512151212016-09-08
M17451671Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips 516751672016-09-08
M1745100A1Serim® GUARDIAN™ Residual Chlorine Test Strips5100A5100A2016-08-29
M17451052Serim® GUARDIAN™ Residual Peroxide Test Strips 510551052016-09-08
M17451092Serim® GUARDIAN™ HiSENSE™ Test Kit 510951092016-09-19
M1745119C2Serim® GUARDIAN™ Blood Leak Test Strips5119C5119C2017-02-12
M17451212Serim® DISINTEK™ OPA Test Strips 512151212016-09-08
M1745136A1Serim® DISINTEK™ GTA 1.5% Test Strips 5136A5136A2016-09-08
M1745116A1Serim® GUARDIAN™ Bicarb pH II Test Strips 5116A5116A2016-09-19
M17451061Serim® GUARDIAN™ Peracetic Acid Test Strips 510651062016-09-08
M17451221Serim® PeriScreen™ Test Strips 512251222016-09-08
M17451191Serim® GUARDIAN™ Blood Leak Test StripsBlood Leak 50's51192026-01-29
M17451121Serim® GUARDIAN™ Residual Formaldehyde Test Strips 511251122016-09-08
M17451190Serim® GUARDIAN™ Blood Leak Test StripsBlood Leak 50's51192026-01-29
M1745140K2Serim® PyloriTek® Test Kit 05140K05140K2016-09-19
M1745100C1Serim® GUARDIAN™ Residual Chlorine Test Strips 5100C5100C2016-08-29

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