Acucy System Universal Drawer

GUDID 00742860100475

SEKISUI DIAGNOSTICS, LLC

Photometric/spectroscopic immunoassay analyser IVD

• Primary Device ID: 00742860100475
• NIH Device Record Key: a6fafa7c-0f22-49ea-8c7b-d4d474696a84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acucy System Universal Drawer
• Version Model Number: 1051
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00742860100475 [Primary]

FDA Product Code

• PSZ: Devices Detecting Influenza A, B, And C Virus Antigens

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: 2026-03-09
• Device Publish Date: 2026-02-27

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

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• 00742860100475 - Acucy System Universal Drawer: 2026-03-09
• 00742860100475 - Acucy System Universal Drawer: 2026-03-09
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• 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