AccessGUDID - DEVICE: VIDAS® Varicella-Zoster IgG (03573026064518)

GUDID

Device Identifier (DI) Information

Brand Name: VIDAS® Varicella-Zoster IgG
Version or Model: 30217
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026064518
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum.

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):	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?
49621	Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection 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 [?]
K923122	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: 01e40ef2-078a-4867-b4bf-e564e0fdb449
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016