Hemoccult 395067

GUDID 15099590227302

Hemoccult ICT Immunochemical Fecal Occult Blood Test

Beckman Coulter, Inc.

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 15099590227302
• NIH Device Record Key: dd1a7bd9-43f9-42e2-b3cb-814e5a370618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemoccult
• Version Model Number: 395067
• Catalog Number: 395067
• 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	15099590227302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080812

FDA Product Code

• KHE: Reagent, Occult Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Hemoccult]

• 15099590390341: Hemoccult Sensa Single Slides without Developer (box of 100)
• 15099590231972: Hemoccult Single Slides (BX/100)
• 15099590231965: Hemoccult Single Slides - CS/1000
• 15099590227302: Hemoccult ICT Immunochemical Fecal Occult Blood Test
• 15099590226879: Hemoccult Tape (2 Kits/BX)
• 15099590226794: Hemoccult Sensa Dev (20 15 mL/CS)
• 15099590226770: Hemoccult II Sensa Dispensapak Plus
• 15099590224776: Hemoccult Sensa Single Slide with Developer and Applicators
• 15099590224707: Hemoccult Sensa Sng Sld-CS/1000
• 15099590221799: Hemoccult II Dispensapak
• 15099590221782: Hemoccult II Dispensapak Plus
• 15099590221751: Hemoccult II Slides
• 15099590221669: Hemoccult ICT - 40 Patient Screening Kit
• 15099590221461: HEMOCCULT ICT COLLECTION CARDS
• 15099590221157: Hemoccult ICT Immunochemical Fecal Occult Blood Test Controls
• 15099590220990: Hemoccult Dev (20 15 mL Btl/Case)
• 15099590180072: Hemoccult ICT 2 Day- 50 Patient Screening Kit