intelliPATH MAX

GUDID 00847627033796

BIOCARE MEDICAL LLC

Microscope slide stainer IVD
Primary Device ID00847627033796
NIH Device Record Keyc5dade5a-935f-4455-9d42-7105af07c5f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameintelliPATH MAX
Version Model NumberIPMX0001INTL-R
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627033796 [Primary]

FDA Product Code

KPASlide Stainer, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-25
Device Publish Date2024-07-17

On-Brand Devices [intelliPATH MAX]

00847627033666IPMX0001US-R
00847627033604IPMX0001US
00847627033796IPMX0001INTL-R
00847627033673IPMX0001INTL

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