HbA1c Assay SK350-60

GUDID 00628063401147

SEKISUI DIAGNOSTICS, LLC

Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 00628063401147
• NIH Device Record Key: 9ef037f8-f0e6-44fc-86fc-846c79e4cc03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HbA1c Assay
• Version Model Number: SK350-60
• Catalog Number: SK350-60
• 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	00628063401147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173206

FDA Product Code

• PDJ: Hemoglobin A1c test system

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: 2018-10-25
• Device Publish Date: 2018-09-24

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