ORTHO-CLINICAL DIAGNOSTICS, INC.

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

Acid, uric, uricase (colorimetric) (KNK) (1) BROMCRESOL GREEN DYE-BINDING, ALBUMIN (CIX) (1) C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL (DCK) (1) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) Colorimetry, cholinesterase (DIH) (1) Drug mixture control materials (DIF) (1) FLUOROMETER, FOR CLINICAL USE (KHO) (1) PHOTOMETRIC METHOD, AMMONIA (JID) (1) PHOTOMETRIC METHOD, MAGNESIUM (JGJ) (1) Photometric method, iron (non-heme) (JIY) (1)

Premarket Exempt

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VITROS - 10758750000012 Catalog Number : 1726926

Device Description : VITROS Chemistry Products AMON Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JID

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000067 Catalog Number : 1792357

Device Description : VITROS Chemistry Products TDM Performance Verifier II

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000166 Catalog Number : 1882208

Device Description : VITROS Chemistry Products Calibrator Kit 1

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000241 Catalog Number : 1914605

Device Description : VITROS Chemistry Products CHE Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : DIH

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000265 Catalog Number : 1921204

Device Description : VITROS Chemistry Products Mg Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000272 Catalog Number : 1922814

Device Description : VITROS ECiQ Immunodiagnostic System

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000289 Catalog Number : 1924547

Device Description : VITROS Chemistry Products Fe Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : JIY

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000296 Catalog Number : 1926740

Device Description : VITROS Chemistry Products CRP Slides

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000340 Catalog Number : 1943927

Device Description : VITROS Chemistry Products URIC Slides

Device Class : 1

Duns Number: 623873044

Premarket Exempt : No

Product Code : KNK

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000388 Catalog Number : 1988211

Device Description : VITROS Chemistry Products ALB Slides

Device Class : 2

Duns Number: 623873044

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

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