AccessGUDID - DEVICE: intelliPATH FLX Automated Slide Staining System (00847627031716)

GUDID

Device Identifier (DI) Information

Brand Name: intelliPATH FLX Automated Slide Staining System
Version or Model: IPS0001US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOCARE MEDICAL LLC

Primary DI Number: 00847627031716
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806617825 *Terms of Use

Device Description: No description.

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):	Yes
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?
65302	Microscope slide maker/digital imaging analyser IVD	An electronic benchtop device intended to be used in a histopathology laboratory for: 1) the automated preparation and staining of a clinical specimen (e.g., whole blood) on a microscope examination slide or slide-like cartridge; 2) microscopy digital scanning/imaging; and 3) software-assisted analysis/interpretation of the acquired images. It consists of an integrated unit with built-in motorized specimen preparation stage, digital microscope, user interface, and clinical application-specific artificial intelligence (AI)/deep learning software. 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: 4e19db60-e3f7-4ece-8ba8-e4c4f1edf7d2
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022