QuickGel Applicator Blade and Shallow Well Cups

Basic Information

• Brand Name: QuickGel Applicator Blade and Shallow Well Cups
• Primary DI: M5255521340
• Version / Model: 552134
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 079396131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8bac0406-f154-4018-8d99-2304ef49355f

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JBD	SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN	Hematology	864.7440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59807	Inherited haemoglobinopathy IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M5255521340	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992199	000