AccessGUDID - DEVICE: Measles IgG IFA Slide Only Kit (G5229031011)

GUDID

Device Identifier (DI) Information

Brand Name: Measles IgG IFA Slide Only Kit
Version or Model: 903101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hemagen Diagnostics, Inc.

Primary DI Number: G5229031011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 147827216 *Terms of Use

Device Description: For the detection and titration of measles IgG antibodies in human sera

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:	Yes
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?
49291	Measles virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Measles virus in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GRE	Antiserum, Fluorescent, Rubeola

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K821249	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: 68717b99-9997-4c0c-b33a-9166bcc87ddc
Public Version Date: October 13, 2023
Public Version Number: 1
DI Record Publish Date: October 05, 2023