HemosIL D-Dimer HS 500

Basic Information

• Brand Name: HemosIL D-Dimer HS 500
• Primary DI: 08426951391615
• Version / Model: 0020500300
• Catalog Number: 00020500300
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-10
• Public Version: 3
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: 597142b3-3259-43d3-aa91-389b0427d9e6

Device Description

HemosIL D-Dimer HS 500 (XL)

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
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	864.7320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47346	D-dimer IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426951391615	GS1

Customer Contacts

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

Storage Conditions

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