Serim® PeriScreen™ Test Strips 5122

GUDID M17451221

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

SERIM RESEARCH CORPORATION

Leukocyte esterase IVD, kit, rapid colorimetric, clinical

• Primary Device ID: M17451221
• NIH Device Record Key: b2820dbd-6d26-4679-ad2d-0a8b23da23ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serim® PeriScreen™ Test Strips
• Version Model Number: 5122
• Catalog Number: 5122
• Company DUNS: 605151018
• Company Name: SERIM RESEARCH CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M17451220 [Unit of Use]
HIBCC	M17451221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000578

FDA Product Code

• LJX: Test, Urine Leukocyte

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-08

Devices Manufactured by SERIM RESEARCH CORPORATION

• M17451061 - Serim® GUARDIAN™ Peracetic Acid Test Strips: 2024-04-16 SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing
• M17451221 - Serim® PeriScreen™ Test Strips: 2022-11-28Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.
• M17451221 - Serim® PeriScreen™ Test Strips: 2022-11-28 Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.