N-geneous LDL-ST Cholesterol Reagent (R2) 80-5714-00

GUDID 00628063400737

SEKISUI DIAGNOSTICS, LLC

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

• Primary Device ID: 00628063400737
• NIH Device Record Key: c1c9031b-1608-41ca-bacc-73d01911a2bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N-geneous LDL-ST Cholesterol Reagent (R2)
• Version Model Number: 80-5714-00
• Catalog Number: 80-5714-00
• 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	00628063400737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992766

FDA Product Code

• MRR: SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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

• 00628063400768: 80-5729-02
• 00628063400737: 80-5714-00