AccessGUDID - DEVICE: ASI Mumps IgG EIA Test (00816057020614)

GUDID

Device Identifier (DI) Information

Brand Name: ASI Mumps IgG EIA Test
Version or Model: NC-860096-AG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NC-860096-AG
Company Name: ARLINGTON SCIENTIFIC, INC.

Primary DI Number: 00816057020614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785966607 *Terms of Use

Device Description: Detection of Mumps antibody

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:	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?
49332	Mumps virus 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 Mumps virus in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980059	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
Device Size Text, specify: 96 Test

Device Record Status

Public Device Record Key: dd1dbcdd-f211-4746-9311-ad8796cdc7b3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 08, 2016