AccessGUDID - DEVICE: Mumps Virus IgG ELISA (00840239038463)

GUDID

Device Identifier (DI) Information

Brand Name: Mumps Virus IgG ELISA
Version or Model: EIA-3846
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3846
Company Name: DRG International Inc

Primary DI Number: 00840239038463
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).

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):	No
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?
49338	Mumps virus immunoglobulin A (IgA)/IgG/IgM 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 A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) 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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Conjugate
Device Size Text, specify: Diluent G
Total Volume: 20 Milliliter
Device Size Text, specify: Wash Buffer
Device Size Text, specify: Cut Off
Total Volume: 100 Milliliter
Total Volume: 15 Milliliter
Total Volume: 50 Milliliter
Total Volume: 3 Milliliter
Device Size Text, specify: Stop Solution
Device Size Text, specify: Controls +/-
Device Size Text, specify: Substrate TMB
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: 6b4f3c4a-b2bb-4aa9-ab4c-a1d5c7ab7881
Public Version Date: August 09, 2021
Public Version Number: 3
DI Record Publish Date: March 20, 2019