HemosIL Chromogenic Factor IX

Basic Information

• Brand Name: HemosIL Chromogenic Factor IX
• Primary DI: 00195226001129
• Version / Model: 0020012900
• Catalog Number: 0020012900
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-09
• Public Version: 1
• Public Version Date: 2024-07-17
• Public Version Status: New
• Public Device Record Key: 0628a009-da5f-42e2-8ed6-381e12a0a60a

Device Description

HemosIL Chromogenic Factor IX

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56249	Coagulation factor IX IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative detection of coagulation factor IX in a clinical specimen, using a chromogenic method. Factor IX deficiency may result in a hereditary bleeding disorder known as haemophilia B or Christmas disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195226001129	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230852	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius