FDA.reportPublic FDA data

Serim® PeriScreen™ Test Strips

Primary DI
M17451221
Brand
Serim® PeriScreen™ Test Strips
Company
SERIM RESEARCH CORPORATION
Model
5122
Catalog number
5122
Device description
Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.
Published
2016-09-08
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
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000578000SERIM LEUKOCYTE ESTERASE TEST STRIPSSerim Research Corp.2000-05-05LJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M17451221PrimaryHIBCC0
M17451220Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Leukocyte esterase IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of leukocyte esterase in a clinical specimen within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
605151018
Device count
10
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
M1745140K1Serim® PyloriTek® Test Kit 05140K05140K2016-09-19
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
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
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.LJX2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.LJX2026-04-16
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
06942598204542Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
06942598216781Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.LJX2026-03-26
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.LJX2026-03-23
06974246462936Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462943Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462950Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462967Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462974Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462981Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
00860015215833Vivoo At-Home UTI Test StripsVIVOSENS INC.LJX2026-02-13
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
06974246462363T Testahead URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2025-07-07
06974246462370T Testahead URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2025-07-07
00682607003433Mission Urinary Tract Infection (UTI) Test stripsAcon Laboratories, Inc.LJX2025-05-12
20682607610031Mission Urinary Tract Infection (UTI) Test stripsACON LABORATORIES, INC.LJX2025-05-12
00846036009774GOODSENSEGEISS, DESTIN & DUNN, INCLJX2025-01-16
00860011489122Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.LJX2024-11-25
00850054026729QMedix™Diagnostic Automation, Inc.LJX2024-10-29
06974246461663Welcheck URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-10-16
06974246461670Welcheck URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-10-16
06971257037177urinalysis stripsWeihai Kangzheng Medical Equipment Technology Co., LtdLJX2024-06-22
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2024-06-14