Genetic Screening Processor 2021-0010

GUDID 06438147311040

The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitrati

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, automated
Primary Device ID06438147311040
NIH Device Record Key99744322-967c-48af-9d27-6d4e92e1c160
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenetic Screening Processor
Version Model Number2021-0010
Catalog Number2021-0010
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
GS106438147311040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

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