intelliPATH Plus

GUDID 00847627033031

BIOCARE MEDICAL LLC

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD

• Primary Device ID: 00847627033031
• NIH Device Record Key: c722e91c-2915-46ae-b2e4-02e3f6390ffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: intelliPATH Plus
• Version Model Number: IPPLS0001INTL-R
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627033031 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [intelliPATH Plus ]

• 00847627032768: IPPLS0001US-R
• 00847627032751: IPPLS0001US
• 00847627033031: IPPLS0001INTL-R
• 00847627032775: IPPLS0001INTL