Ammonia 05401739190

GUDID 04015630927005

Roche Diagnostics GmbH

Ammonia IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04015630927005
• NIH Device Record Key: 4dbef540-cb82-4fee-ad1d-ca341d559fca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ammonia
• Version Model Number: 5401739190
• Catalog Number: 05401739190
• 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	04015630927005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972250

FDA Product Code

• JIF: ENZYMATIC METHOD, AMMONIA

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 [Ammonia]

• 04015630928071: 5975581190
• 04015630927005: 5401739190
• 04015630914708: 20766682322