Phosphate (Inorganic) ver.2 03183793122

GUDID 04015630918973

Roche Diagnostics GmbH

Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

• Primary Device ID: 04015630918973
• NIH Device Record Key: 579ad84d-6d76-4f93-8f0f-a79d7b1ed436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phosphate (Inorganic) ver.2
• Version Model Number: 03183793122
• Catalog Number: 03183793122
• 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: false
• 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	04015630918973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951595

FDA Product Code

• CEO: Phosphomolybdate (colorimetric), inorganic phosphorus

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: 2021-06-04
• Device Publish Date: 2021-05-27

On-Brand Devices [Phosphate (Inorganic) ver.2]

• 07613336121481: 08058610190
• 04015630925094: 5171377190
• 04015630918973: 03183793122