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

Calibrator, secondary (JIT) (2) CALIBRATOR, PRIMARY (JIS) (1) CALIBRATOR, SECONDARY (JIT) (1) ENZYME IMMUNOASSAY, AMPHETAMINE (DKZ) (1) ENZYME IMMUNOASSAY, BARBITURATE (DIS) (1) ENZYME IMMUNOASSAY, CANNABINOIDS (LDJ) (1) Enzyme immunoassay, benzodiazepine (JXM) (1) C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL (DCK) (1) LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL (LBS) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750001392 Catalog Number : 6801771

Device Description : VITROS Chemistry Products PALB Performance Verifier I

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001408 Catalog Number : 6801772

Device Description : VITROS Chemistry Products PALB Performance Verifier II

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001552 Catalog Number : 6801873

Device Description : VITROS Chemistry Products FS Calibrator 1

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001637 Catalog Number : 6801888

Device Description : VITROS Chemistry Products hsCRP Performance Verifier II

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001668 Catalog Number : 6801895

Device Description : VITROS Chemistry Products dHDL Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001675 Catalog Number : 6801896

Device Description : VITROS Chemistry Products Calibrator Kit 25

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001743 Catalog Number : 6801988

Device Description : VITROS Chemistry Products BARB Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001750 Catalog Number : 6801989

Device Description : VITROS Chemistry Products BENZ Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001774 Catalog Number : 6801991

Device Description : VITROS Chemistry Products AMPH Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001804 Catalog Number : 6801994

Device Description : VITROS Chemistry Products THC Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

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