intelliPATH FLX Automated Slide Staining System

Basic Information

• Brand Name: intelliPATH FLX Automated Slide Staining System
• Primary DI: 00847627031716
• Version / Model: IPS0001US
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 4e19db60-e3f7-4ece-8ba8-e4c4f1edf7d2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPA	Slide Stainer, Automated	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847627031716	GS1