Chemstrip 2 LN Test Strips 11895460160

GUDID 00075537171523

Roche Diagnostics GmbH

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00075537171523
• NIH Device Record Key: b3349a4c-8a2d-4d38-bd0f-a3f3065a59c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemstrip 2 LN Test Strips
• Version Model Number: 11895460160
• Catalog Number: 11895460160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075537171523 [Primary]

FDA Product Code

• LJX: TEST, URINE LEUKOCYTE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-26
• Device Publish Date: 2021-01-18

Devices Manufactured by Roche Diagnostics GmbH

• 07613336218426 - Elecsys Prolactin II: 2024-10-16
• 07613336160367 - Elecsys Anti-HBs II: 2024-10-10
• 07613336230367 - Elecsys Anti-HBs II: 2024-08-28
• 07613336217801 - Elecsys FSH: 2024-08-27
• 07613336218327 - Elecsys CA 125 II: 2024-08-21
• 07613336218464 - Elecsys Toxo IgM: 2024-08-21
• 04015630928941 - Homocysteine Calibrator Kit: 2024-08-20
• 04015630037025 - cobas b 123 Fluid Pack 400: 2024-08-07