Elecsys N-MID Osteocalcin 07027591190

GUDID 04015630940462

Roche Diagnostics GmbH

Osteocalcin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630940462
• NIH Device Record Key: 684c2e4a-ee61-4a40-9f8f-1f58c1337d98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys N-MID Osteocalcin
• Version Model Number: 07027591190
• Catalog Number: 07027591190
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630940462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051297

FDA Product Code

• NEO: SYSTEM, TEST, OSTEOCALCIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-08
• Device Publish Date: 2017-04-21

Devices Manufactured by Roche Diagnostics GmbH

• 07613336182994 - PreciControl Release HBsAg II: 2024-11-15
• 07613336228456 - Elecsys HBsAg II: 2024-11-15
• 07613336183137 - Elecsys HBsAg II Auto Confirm: 2024-11-15
• 07613336183168 - PreciControl HBsAg II: 2024-11-15
• 07613336183236 - PreciControl HBsAg II Auto Confirm: 2024-11-15
• 07613336234402 - navify® Lab Operations: 2024-11-05
• 07613336217665 - Elecsys Total PSA: 2024-11-01
• 07613336217672 - Elecsys free PSA: 2024-11-01