Serim® PeriScreen™ Test Strips

Basic Information

• Brand Name: Serim® PeriScreen™ Test Strips
• Primary DI: M17451221
• Version / Model: 5122
• Catalog Number: 5122
• Company Name: SERIM RESEARCH CORPORATION
• Labeler DUNS: 605151018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 5
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: b2820dbd-6d26-4679-ad2d-0a8b23da23ed

Device Description

Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJX	Test, Urine Leukocyte	Hematology	864.7675	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33738	Leukocyte esterase IVD, kit, rapid colorimetric, clinical	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M17451221	HIBCC
Unit of Use	M17451220	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K000578	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius