DC-TROL Level 2 SM-056

GUDID 00628063400461

SEKISUI DIAGNOSTICS, LLC

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 00628063400461
• NIH Device Record Key: 2af18858-ff44-4a7e-8ea5-9d9adf5334c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-TROL Level 2
• Version Model Number: SM-056
• Catalog Number: SM-056
• 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	00628063400461 [Primary]
GS1	10628063400468 [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

• 10742860100410 - Acucy Printer Paper: 2026-03-09
• 00742860100444 - Acucy Reader A/C Adapter: 2026-03-09
• 00742860100475 - Acucy System Universal Drawer: 2026-03-09
• 50742860100685 - OSOM BVBlue Transport Swabs: 2026-03-03 OSOM BVBlue Transport Swab Set
• 10742860100670 - OSOM COVID-19 Test: 2026-01-27 OSOM COVID-19 Test
• 10742860100052 - OSOM BV Blue 25T Kit: 2026-01-06
• 00742860100062 - OSOM BV Blue Control Kit: 2026-01-06
• 00742860000065 - OSOM Flu SARS-CoV-2 Combo Test: 2025-12-23 OSOM Flu SARS-CoV-2 Combo Test