Elecsys Vitamin D total III 09038078160

GUDID 07613336184615

Vitamin D total G3 Elecsys cobas e 100

Roche Diagnostics GmbH

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336184615
• NIH Device Record Key: c46d6eea-510b-48b8-b631-a27880d538bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Vitamin D total III
• Version Model Number: 09038078160
• Catalog Number: 09038078160
• 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	07613336184615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210901

FDA Product Code

• MRG: SYSTEM, TEST, VITAMIN D

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: 2021-12-15
• Device Publish Date: 2021-12-07

On-Brand Devices [Elecsys Vitamin D total III]

• 07613336184615: Vitamin D total G3 Elecsys cobas e 100
• 07613336172650: Vitamin D total G3 Elecsys E2G 300