HemosIL Low Fibrinogen Control

Basic Information

• Brand Name: HemosIL Low Fibrinogen Control
• Primary DI: 08426950451976
• Version / Model: 00020004200
• Catalog Number: 00020004200
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: e7591c44-a7b8-47c4-9eb0-a0752ad88e33

Device Description

HemosIL Low Fibrinogen Control

Device Characteristics

• Single Use: No
• 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
KQJ	System, Fibrinogen Determination	Hematology	864.7340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32393	Fibrinogen assay (factor I) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950451976	GS1
Unit of Use	18426950451973	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C.