AccessGUDID - DEVICE: Light Diagnostics™ Mumps IFA Kit (04053252329746)

GUDID

Device Identifier (DI) Information

Brand Name: Light Diagnostics™ Mumps IFA Kit
Version or Model: 3140
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3140
Company Name: EMD Millipore Corporation

Primary DI Number: 04053252329746
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 829517072 *Terms of Use

Device Description: Mumps IFA Kit

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?
49339	Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Mumps virus in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GRA	Antiserum, Fluorescent, Mumps Virus

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 50e3f6aa-8771-41ef-a06c-ba7a33177e34
Public Version Date: August 25, 2023
Public Version Number: 2
DI Record Publish Date: November 28, 2022