FIT-CHEK

GUDID M769FITCHEK331

Fecal Immunochemical Test to screen for Colorectal cancer.

Home Access Health Corporation

Home faecal specimen collection kit

• Primary Device ID: M769FITCHEK331
• NIH Device Record Key: 150c5023-9da1-423e-b80f-c4c1ee38a826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT-CHEK
• Version Model Number: 33
• Company DUNS: 848511283
• Company Name: Home Access Health Corporation
• 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: 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
HIBCC	M769FITCHEK331 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-22

On-Brand Devices [FIT-CHEK]

• M769FITCHEK341: Fecal Immunochemical Test to screen for Colorectal cancer.
• M769FITCHEK331: Fecal Immunochemical Test to screen for Colorectal cancer.
• M769FITCHEK361: Fecal Immunochemical Test to screen for Colorectal Cancer.
• M769FITCHEK351: Fecal Immunochemical Test to screen for Colorectal Cancer.