AccessGUDID - DEVICE: TintoStainer 36 Slide (110V) with Report Printer + UPS (B502BSB70290)

GUDID

Device Identifier (DI) Information

Brand Name: TintoStainer 36 Slide (110V) with Report Printer + UPS
Version or Model: TintoStainer 36 (110V)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BSB 7029
Company Name: BIO SB, INC.

Primary DI Number: B502BSB70290
Issuing Agency: HIBCC
Commercial Distribution End Date: November 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: The Bio SB Automated TintoStainer is an automated 36, 48, or 72 slide system for use in Immunohistochemistry (IHC) and Immunocytochemistry (ICC). The TintoStainer is perfect for laboratories that have a need increase work-flow efficiency through automation, yet want to maintain low operating costs. The TintoStainer is a rapid, flexible, open and affordable solution which allows for fast implementation of laboratory protocols while keeping a compact footprint.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23ee9000-7993-4e73-a8e6-cefb6d7e0db3
Public Version Date: March 12, 2025
Public Version Number: 2
DI Record Publish Date: September 30, 2020