AccessGUDID - DEVICE: ImmunoFA Toxoplasma Slides (00613745012018)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoFA Toxoplasma Slides
Version or Model: 800-1201
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1201
Company Name: Genbio

Primary DI Number: 00613745012018
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: Toxoplasma Slides for use with ImmunoFA Toxoplasma kits

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?
52453	Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen.	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: 10 slides, 10 tests each slide

Device Record Status

Public Device Record Key: dc5cfdb0-a693-499a-aceb-5b087a040c40
Public Version Date: August 29, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016