hema-screen SPECIFIC

GUDID 20722355001092

Immunological Fecal Occult Blood test

IMMUNOSTICS COMPANY, INC

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

• Primary Device ID: 20722355001092
• NIH Device Record Key: 9325d302-089c-4bbd-a3a6-c0fd181dce23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hema-screen SPECIFIC
• Version Model Number: HSSPCAS-25
• Company DUNS: 119214195
• Company Name: IMMUNOSTICS COMPANY, INC
• Device Count: 25
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355001095 [Primary]
GS1	20722355001092 [Package]; Contains: 10722355001095; Package: Case of 10 [10 Units]; In Commercial Distribution
GS1	80722355001094 [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: 2020-04-06
• Device Publish Date: 2016-09-21

On-Brand Devices [hema-screen SPECIFIC]

• 10722355002689: Immunological Fecal Occult Blood test
• 20722355001092: Immunological Fecal Occult Blood test
• 10722355001088: Immunological Fecal Occult Blood test
• 20722355001078: Immunological Fecal Occult Blood test
• 10722355001118: Immunological Fecal Occult Blood test
• 20722355001108: Immunological Fecal Occult Blood test