N-geneous LDL Cholesterol Reagent (R2) 80-4601-00

GUDID 00628063400683

SEKISUI DIAGNOSTICS, LLC

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

• Primary Device ID: 00628063400683
• NIH Device Record Key: f009a4be-4568-4417-8a18-ad4507e190dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N-geneous LDL Cholesterol Reagent (R2)
• Version Model Number: 80-4601-00
• Catalog Number: 80-4601-00
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• 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: true
• 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	00628063400683 [Primary]

FDA Product Code

• LBR: LDL & VLDL PRECIPITATION, HDL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

On-Brand Devices [N-geneous LDL Cholesterol Reagent (R2)]

• 00628063400706: 80-4607-00
• 00628063400683: 80-4601-00