Acucy Calibration Device

GUDID 00742860100345

SEKISUI DIAGNOSTICS, LLC

Optical instrument calibration/verification reference standard IVD Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable

• Primary Device ID: 00742860100345
• NIH Device Record Key: 387cfaef-aa3e-454a-9492-d23d2a98031d
• Commercial Distribution Discontinuation: 2019-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acucy Calibration Device
• Version Model Number: 1031
• 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: 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	00742860100345 [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: 2019-10-02
• Device Publish Date: 2019-09-24

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