CHEMSTRIP 9 URINE TEST STRIPS 11895427160

GUDID 00075537171097

Roche Diagnostics GmbH

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• Primary Device ID: 00075537171097
• NIH Device Record Key: aec65a44-6c41-47e2-8b47-868d68726c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHEMSTRIP 9 URINE TEST STRIPS
• Version Model Number: 11895427160
• Catalog Number: 11895427160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075537171097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896454

FDA Product Code

• JIL: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [CHEMSTRIP 9 URINE TEST STRIPS]

• 00075537171097: 11895427160
• 00075537007433: 11895397160