ColoScreen Developer

GUDID M5255000910

HELENA LABORATORIES CORPORATION

Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical

• Primary Device ID: M5255000910
• NIH Device Record Key: be27c997-58a2-439d-bcc6-3d6507af6bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColoScreen Developer
• Version Model Number: 500091
• Company DUNS: 079396131
• Company Name: HELENA LABORATORIES 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: false
• 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

Customer Support Contacts

• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5255000910 [Primary]
HIBCC	M52550771 [Package]; Package: Box [20 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-08-18

Devices Manufactured by HELENA LABORATORIES CORPORATION

• M52518360 - V8 Urine Preparation Buffer: 2023-09-18
• M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit: 2023-09-18
• M52510680010 - SPIFE Touch, CSA 2015 (120V): 2023-09-11
• M52510690000 - SPIFE Touch (230V): 2023-09-11
• M52510880010 - SPIFE 3000 w/ New Pump & Valve (110V): 2023-09-11
• M52510880020 - SPIFE 3000, "CE 2011" (120V): 2023-09-11
• M52510890010 - SPIFE 3000 w/ New Pump & Valve (220V): 2023-09-11
• M52510890020 - SPIFE 3000, "CE 2011" (230V): 2023-09-11