Icon 395160

GUDID 15099590625924

ICON HP (30 Tests)

Beckman Coulter, Inc.

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

• Primary Device ID: 15099590625924
• NIH Device Record Key: 86506b25-52f7-4ede-9788-3c7d70dbeb8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon
• Version Model Number: 395160
• Catalog Number: 395160
• 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	15099590625924 [Primary]

FDA Product Code

• LYR: Helicobacter Pylori

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: 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