AccessGUDID - DEVICE: ImmunoFA Toxoplasma IgG (00613745012001)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoFA Toxoplasma IgG
Version or Model: 800-1200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1200
Company Name: Genbio

Primary DI Number: 00613745012001
Issuing Agency: GS1
Commercial Distribution End Date: August 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

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?
52437	Toxoplasma gondii 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 the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GLZ	Antigens, If, Toxoplasma Gondii

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K803134	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: 100 tests

Device Record Status

Public Device Record Key: df948836-8173-4aca-ad0a-1008ba188322
Public Version Date: August 29, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016