NA

Basic Information

• Brand Name: NA
• Primary DI: 05056080500058
• Version / Model: R30852601
• Company Name: REMEL EUROPE LIMITED
• Labeler DUNS: 232600853
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2025-06-09
• Public Version Status: Update
• Public Device Record Key: e82695be-d4bb-4d24-8b2c-aa3f8dafc7c0
• Distribution End Date: 2025-02-03

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
56108	Fibrin/fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fibrin and/or fibrinogen degradation products (FDP) in a clinical specimen within a short period relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to aid in the diagnosis of disseminated intravascular coagulation (DIC). 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	05056080500058	GS1

Customer Contacts

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