AccessGUDID - DEVICE: Cytomegalovirus / CMV IgM IFA 96 Test (G5229021121)

GUDID

Device Identifier (DI) Information

Brand Name: Cytomegalovirus / CMV IgM IFA 96 Test
Version or Model: 902112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hemagen Diagnostics, Inc.

Primary DI Number: G5229021121
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 cytomegalovirus (CMV) IgM 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?
49725	Cytomegalovirus (CMV) immunoglobulin M (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 M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus

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: 39f5db60-e873-47e1-90d9-276f96fb026b
Public Version Date: October 16, 2023
Public Version Number: 1
DI Record Publish Date: October 06, 2023