Hema-Screen Lab Pack

Basic Information

• Brand Name: Hema-Screen Lab Pack
• Primary DI: 00657498129012
• Version / Model: 1290-100
• Catalog Number: 1290-100
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 375fcec4-3c19-4092-b806-226ebe39f16d

Device Description

Hema-Screen is a guaiac slide test for the qualitative detection of fecal occult blood.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
Primary	00657498129012	GS1
Unit of Use	00657498129029	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius