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

General Purpose Reagent (PPM) (3) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (2) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (1) Blood, Occult, Colorimetric, In Urine (JIO) (1) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Counter, Cell, Automated (Particle Counter) (GKL) (1) Counter, Urine Particle (LKM) (1) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (1) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (1) Diluent, Blood Cell (GIF) (1) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (1) Mixture, Hematology Quality Control (JPK) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1) Test, Urine Leukocyte (LJX) (1) Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (1) Urinalysis Controls (Assayed And Unassayed) (JJW) (1) Automated Urinalysis System (KQO) (1)

Premarket Exempt

No Yes

Clear

iQ®200 - 10837461002192 Catalog Number : 800-3105

Device Description : iQ® Lamina™ Cradle

Device Class : 2

Duns Number: 098240690

Premarket Exempt : No

Product Code : LKM

Prescription Use : Yes

Device Count : 1

Iris® - 10837461002239 Catalog Number : 800-3202

Device Description : Iris® Diluent Pack (NA)

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : Yes

Device Count : 1

Iris® - 10837461002260 Catalog Number : 800-3203

Device Description : Iris® System Cleanser Pack (NA/INTL)

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002307 Catalog Number : 800-3213

Device Description : iQ® Body Fluids Lysing Reagent (NA/INTL)

Device Class : 1

Duns Number: 098240690

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002345 Catalog Number : 800-3219

Device Description : iQ® Body Fluids Controls-Level I and Level II (NA/INTL)

Device Class : 2

Duns Number: 098240690

Premarket Exempt : No

Product Code : JPK

Prescription Use : Yes

Device Count : 1

iQ®200 - 10837461002376 Catalog Number : 800-3236

Device Description : iQ® Lamina™ Case of 2 x 7 L

Device Class :

Duns Number: 098240690

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 2

iQ®200 - 10837461002475 Catalog Number : 800-3704

Device Description : iQ®200 Body Fluids Module (CD only)

Device Class : 2

Duns Number: 098240690

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

iChem - 10837461002529 Catalog Number : 800-7005

Device Description : iChem®10 SG Urine Chemistry Strips

Device Class : 1

Duns Number: 098240690

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

vChem® - 10837461002536 Catalog Number : 800-7007

Device Description : vChem®10 SG Urine Chemistry Strips

Device Class : 2

Duns Number: 098240690

Premarket Exempt : No

Product Code : JIL

Prescription Use : Yes

Device Count : 1

IRISpec - 10837461002611 Catalog Number : 800-7211

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

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