Serim® PyloriTek® Test Kit 05140K

GUDID M1745140K2

The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

SERIM RESEARCH CORPORATION

Helicobacter pylori urease IVD, kit, chromogenic

• Primary Device ID: M1745140K2
• NIH Device Record Key: b3f89921-9db5-4b95-bfa5-a0baba6fd881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serim® PyloriTek® Test Kit
• Version Model Number: 05140K
• Catalog Number: 05140K
• Company DUNS: 605151018
• Company Name: SERIM RESEARCH CORPORATION
• Device Count: 20
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M1745140D2 [Package]; Contains: M1745140K1; Package: Kit [1 Units]; Discontinued: 2023-11-30; Not in Commercial Distribution
HIBCC	M1745140K0 [Unit of Use]
HIBCC	M1745140K1 [Primary]
HIBCC	M1745140K2 [Package]; Contains: M1745140K1; Package: Kit [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953632

FDA Product Code

• LYR: Helicobacter Pylori

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: 2026-02-06
• Device Publish Date: 2016-09-19

On-Brand Devices [Serim® PyloriTek® Test Kit ]

• M1745140S2: The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presump
• M1745140K2: The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presump