intelliPATH MAX

GUDID 00847627033604

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

Primary Device ID	00847627033604
NIH Device Record Key	749b82ee-a8b0-4a66-b89b-8fb20871b69e
Commercial Distribution Status	In Commercial Distribution
Brand Name	intelliPATH MAX
Version Model Number	IPMX0001US
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	00847627033604 [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	2024-05-08
Device Publish Date	2024-04-30

On-Brand Devices [intelliPATH MAX]

00847627033666	IPMX0001US-R
00847627033604	IPMX0001US