Chemstrip 2 LN Test Strips 11895460160

GUDID 00075537171523

Roche Diagnostics GmbH

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• 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

• 07613336224816 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224823 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224830 - MTX Calibrator: 2024-04-02
• 07613336217689 - Elecsys ProBNP II: 2024-02-27
• 04015630929702 - cobas Elecsys AntiTPO: 2024-02-16
• 04015630939626 - Elecsys Anti-TPO: 2024-02-16
• 04015630899548 - Elecsys CalSet TUptake: 2024-02-05
• 04015630899579 - Elecsys Tuptake Assay: 2024-02-05