VFE

Basic Information

• Brand Name: VFE
• Primary DI: 08600000686048
• Version / Model: VE-98
• Catalog Number: VE-98
• Company Name: Ramco Laboratories, Inc.
• Labeler DUNS: 082013897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-26
• Public Version: 1
• Public Version Date: 2019-04-03
• Public Version Status: New
• Public Device Record Key: f15f14a2-6149-4452-ae91-f76b6cc8145f

Device Description

EIA-VON WILLEBR.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
56026	Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08600000686048	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983107	000