IRIS INTERNATIONAL, INC.

IRIS INTERNATIONAL, INC.

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Filters

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

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

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

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

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

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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