Acucy Reader A/C Adapter

GUDID 00742860100444

SEKISUI DIAGNOSTICS, LLC

Basic power supply, reusable

• Primary Device ID: 00742860100444
• NIH Device Record Key: 96478292-dd00-4bed-9942-8f8b7f73538e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acucy Reader A/C Adapter
• Version Model Number: 1043
• 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: true
• 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	00742860100444 [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

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• 10742860100670 - OSOM COVID-19 Test: 2026-01-27 OSOM COVID-19 Test
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• 00742860000065 - OSOM Flu SARS-CoV-2 Combo Test: 2025-12-23 OSOM Flu SARS-CoV-2 Combo Test