ORTHO-CLINICAL DIAGNOSTICS, INC.

Address:6005 Freeport Avenue, Suite 130,Memphis,TN,38141,US

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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

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) BROMCRESOL GREEN DYE-BINDING, ALBUMIN (CIX) (1) CALIBRATOR, SECONDARY (JIT) (1) ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL (CHH) (1) ENZYMATIC METHOD, CREATININE (JFY) (1) Hemoglobin A1c test system (PDJ) (1) LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES (CDT) (1) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE (CFJ) (1) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (1) Single (specified) analyte controls (assayed and unassayed) (JJX) (1) UREASE, PHOTOMETRIC, UREA NITROGEN (CDN) (1) URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM (LPS) (1)

Premarket Exempt

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VITROS - 10758750030156 Catalog Number : 6842956

Device Description : VITROS Chemistry Products HCY 2 Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : LPS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750030163 Catalog Number : 6842957

Device Description : VITROS Chemistry Products HCY 2 Performance Verifier I, II, III

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750030729 Catalog Number : 6842905

Device Description : VITROS Chemistry Products HbA1c Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : PDJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750030736 Catalog Number : 6842906

Device Description : VITROS Chemistry Products Calibrator Kit 31

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750031108 Catalog Number : 6844430

Device Description : VITROS Chemistry Products LDHI Slides

Device Class : 2

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750031610 Catalog Number : 6844461

Device Description : VITROS XT 7600 Integrated System

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

VITROS - 10758750031757 Catalog Number : 6844291

Device Description : VITROS XT Chemistry Products ALTV-AST Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : Yes

Device Count : 1

VITROS - 10758750031764 Catalog Number : 6844292

Device Description : VITROS XT Chemistry Products TRIG-CHOL Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : CDT, CHH

Prescription Use : Yes

Device Count : 1

VITROS - 10758750031771 Catalog Number : 6844293

Device Description : VITROS XT Chemistry Products ALB-TP Slides

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750031788 Catalog Number : 6844294

Device Description : VITROS XT Chemistry Products UREA-CREA Slides

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : CDN, JFY

Prescription Use : Yes

Device Count : 1

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