AccessGUDID - DEVICE: West Nile Virus IgG DxSelect™ - IgG Antigen Wells (10816101022349)

GUDID

Device Identifier (DI) Information

Brand Name: West Nile Virus IgG DxSelect™ - IgG Antigen Wells
Version or Model: EL0351
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EL0351
Company Name: DIASORIN MOLECULAR LLC

Primary DI Number: 10816101022349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080271715 *Terms of Use

Device Description: No description.

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:	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?
49060	West Nile virus immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to West Nile virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOP	Elisa, Antibody, West Nile Virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031953	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: 47e3d6e3-2b93-48a4-9101-20d49b7c342b
Public Version Date: July 08, 2024
Public Version Number: 4
DI Record Publish Date: July 11, 2017