OSOM ULTRA PLUS FLU A&B Test

GUDID 10742860100397

SEKISUI DIAGNOSTICS, LLC

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• Primary Device ID: 10742860100397
• NIH Device Record Key: 4ab5efae-e569-40f9-9a6b-c210acce8674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM ULTRA PLUS FLU A&B Test
• Version Model Number: 1032
• 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: true
• 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	00742860100390 [Primary]
GS1	10742860100397 [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: 2022-06-10
• Device Publish Date: 2020-06-01

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