Early Discovery

Basic Information

• Brand Name: Early Discovery
• Primary DI: 10722355002740
• Version / Model: HSED-3
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 0557e4bf-06bd-42b9-9b3c-62c85de87041

Device Description

Fecal Occult Blood IVD, Guaiac

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHE	REAGENT, OCCULT BLOOD	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54531	Faecal occult blood IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20722355002747	GS1	Case of 30	30	In Commercial Distribution
Primary	10722355002740	GS1
Unit of Use	80722355002749	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K022755	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not refrigerate or freeze.
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius