AccessGUDID - DEVICE: Histofluor® Rodent LKS Fluorescent Antibody Test System (M749120750211)

GUDID

Device Identifier (DI) Information

Brand Name: Histofluor® Rodent LKS Fluorescent Antibody Test System
Version or Model: 12075-02 (1)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12075-02 (1)
Company Name: IMMUNO CONCEPTS INC

Primary DI Number: M749120750211
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038271904 *Terms of Use

Device Description: Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 23ml.

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?
43503	Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD	One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f35da0e-c510-419e-a881-5a8a97ce9db4
Public Version Date: June 03, 2025
Public Version Number: 3
DI Record Publish Date: February 09, 2021