IRIS INTERNATIONAL, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Automated Urinalysis System (KQO) (5) Counter, Urine Particle (LKM) (4) Urinalysis Controls (Assayed And Unassayed) (JJW) (4) General Purpose Reagent (PPM) (1)

Premarket Exempt

No Yes

Clear

iQ200 - 10837461001256 Catalog Number : 700-3325

Device Description : "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)""iQ200 Sprint 2008 Te "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)""iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA);""iQ200 Sprint 2008 Tested; 800-3082 iQ200 SPRINT Pro w load/unload (NA); 800-3080 IRICELL 3000 PRO w load/unload; 800-3048 IRICELL 3000 Pro (NA)""iQ200 Sprint 2008 Tested; 800-3933 iQ®200 Sprint Plus US (2008 Version) (NA); 800-7713 IRICELL 3000 Plus (NA);800-3079 IRICELL 3000 Plus w/ Load Unload (NA)"

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : KQO, LKM

Prescription Use : Yes

Device Count : 1

iQ200 - 10837461001300 Catalog Number : 700-3345

Device Description : "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA)"iQ2 "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA)"iQ200 Select 2008 Tested; 800-3051 iQ®200 Select Pro (NA); 800-3050 IRICELL 1000 Pro (NA); 800-3048 IRICELL 3000 Pro (NA)"

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : KQO, LKM

Prescription Use : Yes

Device Count : 1

iQ200 - 10837461001317 Catalog Number : 700-3347/700-3375

Device Description : "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)""iQ200 Elite 2008 Test "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)""iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 IRICELL 2000 Pro (NA)"

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : KQO, LKM

Prescription Use : Yes

Device Count : 1

iQ200 - 10837461001355 Catalog Number : 700-3375

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

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : KQO, LKM

Prescription Use : Yes

Device Count : 1

iChem Velocity - 10837461001751 Catalog Number : 700-7177-001

Device Description : 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Inte 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA)2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)"

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : KQO

Prescription Use : Yes

Device Count : 1

IRISpec - 10837461001973 Catalog Number : 800-7211

Device Description : IRISpec CA/CB Twinset

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002031 Catalog Number : 800-3014

Device Description : iQ Precision Kit

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002116 Catalog Number : 800-3102

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002147 Catalog Number : 800-3103

Device Description : iQ® Calibrator Pack

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002178 Catalog Number : 800-3104

Device Description : iQ® Control/Focus Set (NA/INTL)

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : Yes

Device Count : 1

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