Free Protein S Reagent

Basic Information

• Brand Name: Free Protein S Reagent
• Primary DI: M52553630
• Version / Model: 5363
• 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: 2fa82c77-10b5-4488-a862-0e664a6ff27d

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
GGP	TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62195	Protein S IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using an enzyme immunoassay method. It is typically used to aid in the diagnosis of the cause of a venous thromboembolism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52553630	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K904247	000