OSOM Ultra Flu A&B Controls 5 Test 1005

GUDID 00742860100215

OSOM Ultra Flu A&B Controls 5 Test

SEKISUI DIAGNOSTICS, LLC

Influenza A/B virus antigen IVD, control Influenza A/B virus antigen IVD, control

• Primary Device ID: 00742860100215
• NIH Device Record Key: 23b7d9a3-0c47-475a-9724-d28ffd4033f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM Ultra Flu A&B Controls 5 Test
• Version Model Number: 1005
• Catalog Number: 1005
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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	00742860100215 [Primary]
GS1	10742860100212 [Unit of Use]

FDA Product Code

• GNX: ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

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: 2018-03-29
• Device Publish Date: 2017-01-10

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