VisuCon-L(TM) Abnormal Control Plasma

Basic Information

• Brand Name: VisuCon-L(TM) Abnormal Control Plasma
• Primary DI: 10629009121102
• Version / Model: LYABP01
• Company Name: Affinity Biologicals Inc
• Labeler DUNS: 249373515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-10-22
• Public Version: 1
• Public Version Date: 2019-10-30
• Public Version Status: New
• Public Device Record Key: 50d2f28c-3ef6-496d-92e3-6d2bd7e3ba9c

Device Description

A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
GGN	Plasma, Coagulation Control	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10629009121102	GS1
Unit of Use	10629009120013	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius