Uric Acid ver.2 04657608190

GUDID 04015630922550

Roche Diagnostics GmbH

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• Primary Device ID: 04015630922550
• NIH Device Record Key: 403887bf-377d-4595-9465-d17dd4bc6b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uric Acid ver.2
• Version Model Number: 4657608190
• Catalog Number: 04657608190
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630922550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922762

FDA Product Code

• KNK: Acid, uric, uricase (colorimetric)

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: 2021-02-16
• Device Publish Date: 2021-02-08

On-Brand Devices [Uric Acid ver.2]

• 07613336121580: 08058750190
• 04015630925124: 5171857190
• 04015630919154: 3183807190
• 04015630922550: 4657608190