DC-TROL Level 1 SM-052

GUDID 00628063400454

SEKISUI DIAGNOSTICS, LLC

Multiple clinical chemistry analyte IVD, control Multiple clinical chemistry analyte IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 00628063400454
• NIH Device Record Key: 950fc41a-e51c-4ed3-8cf1-8dfae36304be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-TROL Level 1
• Version Model Number: SM-052
• Catalog Number: SM-052
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 10
• 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	00628063400454 [Primary]
GS1	10628063400451 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874772

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

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

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• 00628063401307 - Acetaminophen Calibrator: 2023-05-16
• 00628063401314 - Alinity c Acetaminophen: 2023-05-16
• 00628063401321 - Alinity c Acetaminophen Calibrator: 2023-05-16
• 10742860100397 - OSOM ULTRA PLUS FLU A&B Test: 2022-06-10
• 00628063401222 - DC-TROL LEVELS 1 & 2: 2020-04-07
• 00628063400003 - Carbon Dioxide L3K: 2019-10-21
• 00628063400287 - CARBON DIOXIDE L3K Assay: 2019-10-21