GenASIs™ System

GUDID 07290016630008

APPLIED SPECTRAL IMAGING LTD.

Laboratory analyser operation system software IVD
Primary Device ID07290016630008
NIH Device Record Keya73e2a2b-ee70-44a1-b751-e59e7e8059af
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenASIs™ System
Version Model NumberGenASIs
Company DUNS600741763
Company NameAPPLIED SPECTRAL IMAGING LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS107290016630008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-12

On-Brand Devices [GenASIs™ System]

07290016630015GenASIs
07290016630008GenASIs

Trademark Results [GenASIs]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENASIS
GENASIS
86963882 not registered Dead/Abandoned
kevin Andrews
2016-04-04
GENASIS
GENASIS
86253820 not registered Dead/Abandoned
Applied Spectral Imaging Ltd.
2014-04-16

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