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

LOWRY (COLORIMETRIC), TOTAL PROTEIN (JGP) (3) Single (specified) analyte controls (assayed and unassayed) (JJX) (2) Calibrator, secondary (JIT) (1) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL (DDG) (1) FLUOROMETER, FOR CLINICAL USE (KHO) (1) CALIBRATOR, SECONDARY (JIT) (1)

Premarket Exempt

No Yes

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VITROS - 10758750000593 Catalog Number : 6800120

Device Description : VITROS Chemistry Products UPRO Slides

Device Class : 2

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : JGP

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000616 Catalog Number : 6800189

Device Description : VITROS Chemistry Products Calibrator Kit 10

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000623 Catalog Number : 6800190

Device Description : VITROS Chemistry Products UPRO Performance Verifier I

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JGP

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000630 Catalog Number : 6800191

Device Description : VITROS Chemistry Products UPRO Performance Verifier II

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JGP

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001040 Catalog Number : 6801059

Device Description : VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001330 Catalog Number : 6801759

Device Description : VITROS 250 Chemistry System - Refurbished

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001354 Catalog Number : 6801767

Device Description : VITROS Chemistry Products TRFRN Reagent

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DDG

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001361 Catalog Number : 6801768

Device Description : VITROS Chemistry Products Protein Performance Verifier III

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001378 Catalog Number : 6801769

Device Description : VITROS Chemistry Products ApoA1 Performance Verifier I

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001385 Catalog Number : 6801770

Device Description : VITROS Chemistry Products ApoB Performance Verifier I

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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