DC-TROL LEVELS 1 & 2

GUDID 00628063401222

SEKISUI DIAGNOSTICS, LLC

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 00628063401222
• NIH Device Record Key: 8e819724-7edb-4cde-b9ec-454c57a640e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-TROL LEVELS 1 & 2
• Version Model Number: SM-057
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	00628063401222 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2020-04-07
• Device Publish Date: 2020-03-30

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