ProtoFluor Calibrator - High (5 x 2.5 mL)

Basic Information

• Brand Name: ProtoFluor Calibrator - High (5 x 2.5 mL)
• Primary DI: M52520110
• Version / Model: 2011
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 079396131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 200c9f04-92e0-4317-85a9-10ca1ea7223d

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
JKJ	FLUOROMETRIC MEASUREMENT, PORPHYRINS	Clinical Chemistry	862.1595	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41744	Protoporphyrin IX IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of the porphyrin metabolite protoporphyrin IX in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52520110	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K893038	000