Mikroscan

GUDID 00860002275628

The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan.

MIKROSCAN TECHNOLOGIES, INC.

Microscope slide digital imaging scanner IVD
Primary Device ID00860002275628
NIH Device Record Keycc6bc652-66cb-47e3-ad97-fa950c007036
Commercial Distribution StatusIn Commercial Distribution
Brand NameMikroscan
Version Model NumberSL5-E
Company DUNS079395952
Company NameMIKROSCAN TECHNOLOGIES, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (760) 893-8095
Emailsupport@mikroscan.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002275628 [Primary]

FDA Product Code

IBJLight, Microscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-10
Device Publish Date2020-01-02

On-Brand Devices [Mikroscan]

00860002275628The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly
00860002275611The L5 system from Mikroscan offers the user a live microscope mode using a fully functional, re
00860002275604The dual mode SL5 system from Mikroscan offers the user two completely separate and distinctly d

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