hema-screen SPECIFIC

Basic Information

• Brand Name: hema-screen SPECIFIC
• Primary DI: 10722355001101
• Version / Model: HSSPENV-20
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 7
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: fe6976b9-5e7e-433b-91be-bdea4c526d46

Device Description

Immunological Fecal Occult Blood test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• 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
61352	Faecal specimen collection kit IVD, home-use	A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20722355001108	GS1	Case of 10	10	In Commercial Distribution
Primary	10722355001101	GS1
Unit of Use	80722355001100	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius