ZosterGent VZV Identification Reagent

Basic Information

• Brand Name: ZosterGent VZV Identification Reagent
• Primary DI: 00860002913544
• Version / Model: ZG-VL-US
• Catalog Number: ZG-VL4-US
• Company Name: VIRO RESEARCH, LLC
• Labeler DUNS: 111651798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2020-10-30
• Public Version: 1
• Public Version Date: 2020-11-09
• Public Version Status: New
• Public Device Record Key: a69966a0-3de6-47bf-9b29-8e76b33a7ad2

Device Description

ZosterGent VZV Identification Reagent Test, (4) 3 mL Vials, in Ziplock Pouch

Device Characteristics

• Single Use: No
• 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: 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
GQW	Antigen, Cf, (Including Cf Control), Varicella-Zoster	Microbiology	866.3900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49620	Varicella-zoster virus (VZV) antigen 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 for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860002913506	GS1
Primary	00860002913544	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K942743	000

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Milliliter