LDL-Cholesterol Gen.3 07005768190

GUDID 04015630934591

Roche Diagnostics GmbH

Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04015630934591
• NIH Device Record Key: 84fe0ee1-4976-4a08-8c65-844a975be8a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LDL-Cholesterol Gen.3
• Version Model Number: 7005768190
• Catalog Number: 07005768190
• 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	04015630934591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143691

FDA Product Code

• LBR: LDL & VLDL PRECIPITATION, HDL

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 [LDL-Cholesterol Gen.3]

• 07613336121375: 08057966190
• 04015630934591: 7005768190
• 04015630934584: 7005717190