Cholesterol Gen.2 05168538190

GUDID 04015630924967

Roche Diagnostics GmbH

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04015630924967
• NIH Device Record Key: e5bb7b45-16a2-4e32-8abc-8596d06ad6ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cholesterol Gen.2
• Version Model Number: 5168538190
• Catalog Number: 05168538190
• 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	04015630924967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031824

FDA Product Code

• CHH: ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

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 [Cholesterol Gen.2]

• 04015630918430: 3039773190
• 04015630924967: 5168538190
• 04015630922062: 4718917190