AccessGUDID - DEVICE: TintoStainer Plus Automated System LX (B502BSB7400600)

GUDID

Device Identifier (DI) Information

Brand Name: TintoStainer Plus Automated System LX
Version or Model: BSB-7400-60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-7400-60
Company Name: BIO SB, INC.

Primary DI Number: B502BSB7400600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: Fully automated immunohistochemical system. Completes the whole process from deparaffinization through counterstain, impproving work efficiency in the laboratory. 60 Slides.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
15599	Microscope slide stainer IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	Slide stainer, automated

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 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 377a40a1-c8b8-4736-bce5-93278b89b859
Public Version Date: April 07, 2025
Public Version Number: 1
DI Record Publish Date: March 28, 2025