HDL-Cholesterol plus 3rd generation 05401488190

GUDID 04015630926879

Roche Diagnostics GmbH

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04015630926879
• NIH Device Record Key: 7f517012-17b4-4fff-942d-efde0f909f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDL-Cholesterol plus 3rd generation
• Version Model Number: 5401488190
• Catalog Number: 05401488190
• 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	04015630926879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963213

FDA Product Code

• LBS: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, 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

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