Icon 395100

GUDID 15099590625900

Icon Mono, 30 Test Box

Beckman Coulter, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 15099590625900
• NIH Device Record Key: d554e2d9-817b-4a7e-a088-40734fd004fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon
• Version Model Number: 395100
• Catalog Number: 395100
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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	15099590625900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961024

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Icon]

• 15099590625955: ICON SC Strep A Kit, 25 Tests
• 15099590625948: Icon 20 HCG, Box of 25 Tests
• 15099590625931: ICON DS STREP A, 25 TEST BOX
• 15099590625924: ICON HP (30 Tests)
• 15099590625900: Icon Mono, 30 Test Box