vChem® 800-7007

GUDID 10837461002536

vChem®10 SG Urine Chemistry Strips

IRIS INTERNATIONAL, INC.

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• Primary Device ID: 10837461002536
• NIH Device Record Key: 66ebf5a0-6021-432d-9337-ece0b4baeefc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: vChem®
• Version Model Number: vChem®10 SG Urine Chemistry Strips
• Catalog Number: 800-7007
• Company DUNS: 098240690
• Company Name: IRIS INTERNATIONAL, INC.
• 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: true
• 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	10837461002536 [Primary]

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: 2021-12-22
• Device Publish Date: 2016-09-07

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