Specimen Gate Laboratory 5002-0180

GUDID 06438147153312

Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the stor

Wallac Oy

Clinical laboratory information system
Primary Device ID06438147153312
NIH Device Record Key2566c79c-ef58-4ba8-b8b8-f6314ad926cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecimen Gate Laboratory
Version Model Number5002-0180
Catalog Number5002-0180
Company DUNS540156544
Company NameWallac Oy
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147153312 [Primary]

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-27
Device Publish Date2019-03-19

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