Icon 395097

GUDID 15099590625948

Icon 20 HCG, Box of 25 Tests

Beckman Coulter, Inc.

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

• Primary Device ID: 15099590625948
• NIH Device Record Key: 6542dca5-9e3e-4ed3-98bc-ad0c6deeffe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon
• Version Model Number: 395097
• Catalog Number: 395097
• 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: false
• Lot Batch: true
• 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	15099590625948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020439

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

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: 2019-12-16
• 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