AccessGUDID - DEVICE: ZosterGent VZV Identification Reagent (00860002913551)

GUDID

Device Identifier (DI) Information

Brand Name: ZosterGent VZV Identification Reagent
Version or Model: ZG-VL-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZG-VL5-US
Company Name: VIRO RESEARCH, LLC

Primary DI Number: 00860002913551
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 111651798 *Terms of Use

Device Description: ZosterGent VZV Identification Reagent Test (5) 3 mL Vials, in Ziplock Pouch

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GQW	Antigen, Cf, (Including Cf Control), Varicella-Zoster

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942743	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 6cbbd847-b7e4-4426-84cc-320d023d9297
Public Version Date: November 09, 2020
Public Version Number: 1
DI Record Publish Date: October 30, 2020