hema-screen ER

GUDID 20722355002501

Fecal Occult Blood IVD, Guaiac

IMMUNOSTICS COMPANY, INC

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• Primary Device ID: 20722355002501
• NIH Device Record Key: c90d2c67-76f1-4c8d-9387-86738b91ec1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hema-screen ER
• Version Model Number: HSER-100
• Company DUNS: 119214195
• Company Name: IMMUNOSTICS COMPANY, INC
• Device Count: 100
• 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and light. Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355002504 [Primary]
GS1	20722355002501 [Package]; Contains: 10722355002504; Package: Case of 20 [20 Units]; In Commercial Distribution
GS1	80722355002503 [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: 2022-11-28
• Device Publish Date: 2016-09-23

On-Brand Devices [hema-screen ER]

• 10722355002542: Fecal Occult Blood IVD, Guaiac
• 10722355002535: Fecal Occult Blood IVD, Guaiac
• 20722355002525: Fecal Occult Blood IVD, Guaiac
• 10722355002511: Fecal Occult Blood IVD, Guaiac
• 20722355002501: Fecal Occult Blood IVD, Guaiac