iQ200 700-3375

GUDID 10837461001355

"iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL 2000 Plus (NA)"

IRIS INTERNATIONAL, INC.

Urine analyser IVD, laboratory
Primary Device ID10837461001355
NIH Device Record Key16f1ebc6-8b08-426e-9fd7-3345e1967c7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameiQ200
Version Model NumberElite Plus (US) (2008 Version) (NA)
Catalog Number700-3375
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS110837461001355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQOAutomated Urinalysis System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-09-16
Device Publish Date2016-09-07

On-Brand Devices [iQ200]

10837461001355"iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL
10837461001317"iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)" "iQ200 Elite 2008 Tested; 800-3052 iQ
10837461001300"iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008
10837461001256"iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3081

Trademark Results [iQ200]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IQ200
IQ200
97085503 not registered Live/Pending
HP INGREDIENTS CORP.
2021-10-21
IQ200
IQ200
90759186 not registered Live/Pending
HP INGREDIENTS CORP.
2021-06-07
IQ200
IQ200
90758845 not registered Live/Pending
HP INGREDIENTS CORP.
2021-06-07
IQ200
IQ200
90283388 not registered Live/Pending
HP Ingredients Corp.
2020-10-28
IQ200
IQ200
88654708 not registered Live/Pending
HP INGREDIENTS CORP.
2019-10-15

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