AccessGUDID - DEVICE: LIAISON® EA IgG Serum Control Set (08056771601795)

GUDID

Device Identifier (DI) Information

Brand Name: LIAISON® EA IgG Serum Control Set
Version or Model: 310542
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DIASORIN SPA

Primary DI Number: 08056771601795
Issuing Agency: GS1
Commercial Distribution End Date: February 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 630822989 *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":	Yes
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?
49686	Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c2038f29-4aad-4ea3-b7a6-0181f482e8a8
Public Version Date: February 20, 2019
Public Version Number: 2
DI Record Publish Date: September 24, 2018