SPIFE Nexus IFE-9 Gel Kit

Basic Information

• Brand Name: SPIFE Nexus IFE-9 Gel Kit
• Primary DI: M5255526950
• Version / Model: 552695
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 079396131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-26
• Public Version: 1
• Public Version Date: 2022-06-03
• Public Version Status: New
• Public Device Record Key: 0df149a4-2bab-4b76-b1fb-c86c5a73b98b

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
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53967	Protein electrophoresis IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M5255526950	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973040	000