hema-screen ER developer

GUDID 20722355002556

Fecal Occult Blood Reagent, Guaiac

Immunostics Company, Inc

Faecal occult blood IVD, reagent

• Primary Device ID: 20722355002556
• NIH Device Record Key: 7ccd8009-58d6-4342-bdf8-76f2a4ce06aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hema-screen ER developer
• Version Model Number: HSDVER-8
• Company DUNS: 119214195
• Company Name: Immunostics Company, Inc
• Device Count: 8
• 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: false
• 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(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355002559 [Primary]
GS1	20722355002556 [Package]; Contains: 10722355002559; Package: Case of 10 [10 Units]; In Commercial Distribution
GS1	80722355002558 [Unit of Use]

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: 2025-03-31
• Device Publish Date: 2016-09-23

Devices Manufactured by Immunostics Company, Inc

• 20722355001122 - hema-screen: 2025-03-31 Fecal Occult Blood Reagent, Guaiac
• 10722355001156 - hema-screen SPECIFIC: 2025-03-31 Immunological Fecal Occult Blood test
• 10722355001163 - Detector C-Reactacol: 2025-03-31 A rapid color enhanced latex slide test for the detection of C-Reactive Protein
• 10722355001170 - Detector C-Reactacol: 2025-03-31 A rapid color enhanced latex slide test for the detection of C-Reactive Protein
• 10722355001187 - Detector Lex-CRP: 2025-03-31 A rapid undiluted latex slide test for the detection of C-Reactive Protein
• 10722355001194 - Detector Lex-CRP: 2025-03-31 A rapid undiluted latex slide test for the detection of C-Reactive Protein
• 10722355001200 - Detector Color IM: 2025-03-31 A simple color enhanced slide test for the detection of infectious mononucleosis
• 10722355001217 - Detector Color IM: 2025-03-31 A simple color enhanced slide test for the detection of infectious mononucleosis