AutoDELFIA Sample processor 1297-0110

GUDID 06438147334780

Used with 1235-5220 AutoDELFIA® System (SP and PP).

Wallac Oy

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Primary Device ID06438147334780
NIH Device Record Key1a408461-7998-45ee-a8e1-b947e6d6208a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA Sample processor
Version Model Number1297-0110
Catalog Number1297-0110
Company DUNS540156544
Company NameWallac Oy
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 Datefalse
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
GS106438147334780 [Primary]

FDA Product Code

KHOFluorometer, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-01

On-Brand Devices [AutoDELFIA Sample processor]

06438147334780Used with 1235-5220 AutoDELFIA® System (SP and PP).
06438147116157Used with 1235-514 Fully Automatic DELFIA® System

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