Acucy Flu Test Kit

GUDID 00742860100376

Acucy Influenza A&B Test Kit

SEKISUI DIAGNOSTICS, LLC

Influenza A/B virus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00742860100376
• NIH Device Record Key: 2fce869c-cd5d-41ab-9736-f7968653e8b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acucy Flu Test Kit
• Version Model Number: 1010
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 25
• 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: true
• 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	00742860100376 [Primary]
GS1	10742860100373 [Unit of Use]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-29
• Device Publish Date: 2019-08-20

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

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• 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