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

ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL (DEM) (1) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL (DCK) (1) ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES (DIO) (1) ENZYME IMMUNOASSAY, METHADONE (DJR) (1) ENZYME IMMUNOASSAY, OPIATES (DJG) (1) Enzyme immunoassay, phencyclidine (LCM) (1) Ferrozine (colorimetric) iron binding capacity (JMO) (1) HAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL (DAD) (1) TEST,NATRIURETIC PEPTIDE (NBC) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750001811 Catalog Number : 6801995

Device Description : VITROS Chemistry Products COCM Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001828 Catalog Number : 6801996

Device Description : VITROS Chemistry Products METD Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001835 Catalog Number : 6801997

Device Description : VITROS Chemistry Products OP Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001842 Catalog Number : 6801998

Device Description : VITROS Chemistry Products PCP Reagent

Device Class : U

Duns Number: 623873044

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001873 Catalog Number : 6802001

Device Description : VITROS Chemistry Products dTIBC Reagent

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JMO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001965 Catalog Number : 6802049

Device Description : VITROS Chemistry Products hsCRP Performance Verifier III

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002054 Catalog Number : 6802153

Device Description : VITROS 350 Chemistry System

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002061 Catalog Number : 6802156

Device Description : VITROS Immunodiagnostic Products NT proBNP Reagent Pack

Device Class : 2

Duns Number: 068715424

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002283 Catalog Number : 6802214

Device Description : VITROS Chemistry Products HPT Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : DAD

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002290 Catalog Number : 6802216

Device Description : VITROS Chemistry Products AAT Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DEM

Prescription Use : Yes

Device Count : 1

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