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) (3) Device, Hematocrit Measuring (JPI) (2) Urinalysis Controls (Assayed And Unassayed) (JJW) (2) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (1) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (1) Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (1) General Purpose Reagent (PPM) (1) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (1) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1) Refractometer For Clinical Use (JRE) (1) Test, Urine Leukocyte (LJX) (1) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (1) Blood, Occult, Colorimetric, In Urine (JIO) (1)

Premarket Exempt

No Yes

Clear

iChem® VELOCITY™ - 10837461002628 Catalog Number : 800-7212

Device Description : iChem VELOCITY Urine Chemistry Strips

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : JJB, JIR, JIN, JMA, LJX, JRE, JMT, CEN, CDM, JIO, KQO, JIL

Prescription Use : Yes

Device Count : 1

iChem® VELOCITY™ - 10837461002642 Catalog Number : 800-7217

Device Description : iChem® VELOCITY™ Wash Solution Case of 2 x 7 L

Device Class :

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 2

IRISpec - 10837461002680 Catalog Number : 800-7702

Device Description : IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

iChem® VELOCITY™ - 10837461002710 Catalog Number : 800-7703

Device Description : iChem® VELOCITY™ CalChek Kit

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : JJW

Prescription Use : Yes

Device Count : 1

AX-4280 - 10837461008002 Catalog Number : 800-3517

Device Description : AX-4280 Specific Gravity Calibrator Set

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : KQO

Prescription Use : Yes

Device Count : 1

iChem Velocity - 10837461009375 Catalog Number : 700-7176-001

Device Description : "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automa "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine Chemistry System w load/Unload (NA)""2.5 iChem Velocity Instrument Bring Up and Test; 800-7719 Stand-Alone Velocity (NA)"

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

Product Code : KQO

Prescription Use : Yes

Device Count : 1

StatSpin - 10873037000216 Catalog Number : X00-004998-001

Device Description : StatSpin MP Multipurpose Centrifuge

Device Class : 2

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : JPI

Prescription Use : Yes

Device Count : 1

StatSpin - 10873037000766 Catalog Number : X00-003808-001

Device Description : CritSpin Digital Reader

Device Class : 2

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : JPI

Prescription Use : Yes

Device Count : 1

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