iQ®200 800-3105

GUDID 10837461002192

iQ® Lamina™ Cradle

IRIS INTERNATIONAL, INC.

Urine analyser IVD, laboratory
Primary Device ID10837461002192
NIH Device Record Key284bdd6c-d8c6-435f-bcee-70463f135cdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameiQ®200
Version Model NumberiQ® Lamina™ Cradle
Catalog Number800-3105
Company DUNS098240690
Company NameIRIS INTERNATIONAL, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110837461002192 [Primary]

FDA Product Code

LKMCounter, Urine Particle

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-09-16
Device Publish Date2016-09-07

On-Brand Devices [iQ®200 ]

10837461002475iQ®200 Body Fluids Module (CD only)
10837461002192iQ® Lamina™ Cradle
10837461002116iQ® Lamina™ Case of 4 x 7 L

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