Early Discovery

GUDID 20722355002747

Fecal Occult Blood IVD, Guaiac

IMMUNOSTICS COMPANY, INC

Faecal occult blood IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 20722355002747
• NIH Device Record Key: 0557e4bf-06bd-42b9-9b3c-62c85de87041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Early Discovery
• Version Model Number: HSED-3
• Company DUNS: 119214195
• Company Name: IMMUNOSTICS COMPANY, INC
• Device Count: 3
• 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: false
• OTC Over-The-Counter: true

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

• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate or freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355002740 [Primary]
GS1	20722355002747 [Package]; Contains: 10722355002740; Package: Case of 30 [30 Units]; In Commercial Distribution
GS1	80722355002749 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022755

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: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-23

Devices Manufactured by IMMUNOSTICS COMPANY, INC

• 10722355001293 - Detector hCG: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001309 - Detector hCG: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001316 - Detector hCG: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001330 - Detector hCG Stick: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001347 - Detector hCG Stick: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001354 - Detector hCG Stick: 2023-07-06 For the qualitative detection of hCG in urine
• 10722355001361 - Detector hCG Combi: 2023-07-06 For the qualitative detection of hCG in serum or urine
• 10722355001378 - Detector hCG Combi: 2023-07-06 For the qualitative detection of hCG in serum or urine