SPIFE 4000, Windows 7 (100V)

Basic Information

• Brand Name: SPIFE 4000, Windows 7 (100V)
• Primary DI: M52516220030
• Version / Model: 1622003
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 836287433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-17
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 4dd70178-7a0e-4fe5-be51-8be906814df1

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEF	ELECTROPHORETIC, PROTEIN FRACTIONATION	Clinical Chemistry	862.1630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57837	Electrophoresis analyser IVD	An electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52516220030	HIBCC

Customer Contacts

• Phone: [phone] ext. 1600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K972274	000