AccessGUDID - DEVICE: Varicella Zoster Virus (VZV) IgG ELISA (00840239028082)

GUDID

Device Identifier (DI) Information

Brand Name: Varicella Zoster Virus (VZV) IgG ELISA
Version or Model: EIA-2808
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-2808
Company Name: DRG International Inc

Primary DI Number: 00840239028082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
63913	Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the determination of the avidity index of immunoglobulin G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961012	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
No Device Sizes

Device Record Status

Public Device Record Key: f1c39e6e-a64d-4c47-bc56-af50952052ae
Public Version Date: September 01, 2023
Public Version Number: 1
DI Record Publish Date: August 24, 2023