iChem® VELOCITY™ 800-7212

GUDID 10837461002628

iChem VELOCITY Urine Chemistry Strips

IRIS INTERNATIONAL, INC.

Urine analyser IVD, laboratory
Primary Device ID10837461002628
NIH Device Record Key8e607f08-5aa4-4bbf-9545-3be63ca22c4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameiChem® VELOCITY™
Version Model NumberiChem VELOCITY Urine Chemistry Strips
Catalog Number800-7212
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 Datetrue
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
GS110837461002628 [Primary]

FDA Product Code

JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

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

Devices Manufactured by IRIS INTERNATIONAL, INC.

10837461001973 - IRISpec2023-09-08 IRISpec CA/CB Twinset
10837461002116 - iQ®200 2023-09-08
10837461008002 - AX-42802023-09-08 AX-4280 Specific Gravity Calibrator Set
10873037000766 - StatSpin2023-09-08 CritSpin Digital Reader
10837461001256 - iQ2002022-09-16 "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA
10837461001300 - iQ2002022-09-16 "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008 Tested; 800-3051 iQ®200 Select
10837461001317 - iQ2002022-09-16 "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)" "iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 I
10837461001355 - iQ2002022-09-16 "iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL 2000 Plus (NA)"

Trademark Results [iChem]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ICHEM
ICHEM
86371160 4916632 Live/Registered
PCS Ferguson, Inc.
2014-08-19
ICHEM
ICHEM
86196445 not registered Dead/Abandoned
Fidelity Measurement Technologies, Inc.
2014-02-18
ICHEM
ICHEM
85238913 not registered Dead/Abandoned
Spectrum Laboratories Inc.
2011-02-10
ICHEM
ICHEM
79108145 4366366 Live/Registered
Shanghai World-Prospect Chem Tech Co., Ltd.
2011-09-29
ICHEM
ICHEM
79108145 4366366 Live/Registered
Shanghai World-Prospect Industrial Co.,Ltd.
2011-09-29
ICHEM
ICHEM
78750193 3277570 Live/Registered
BECKMAN COULTER, INC.
2005-11-09

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