QuickScan 2000 Software, Version 2.02

Basic Information

• Brand Name: QuickScan 2000 Software, Version 2.02
• Primary DI: M52516780000
• Version / Model: 1678000
• 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: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 906e0a4f-b43f-410e-aeb7-4dfde6f2947b

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: Yes
• 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
JQJ	DENSITOMETERIC, PROTEIN FRACTIONATION	Clinical Chemistry	862.1630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57836	Densitometry analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of the staining pattern intensity on film, acetate or other composite medium which has been created as the result of electrophoresis, thin-layer chromatography or immunoblot, to separate and/or visualize the individual components of a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52516780000	HIBCC

Customer Contacts

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