ORTHO CLINICAL DIAGNOSTICS

Address:7200 NW 19th Street Suite 401,Miami,FL,33126,US

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Filters

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

Test, hepatitis b (b core, be antigen, be antibody, b core igm) (LOM) (4) Hepatitis a test (antibody and igm antibody) (LOL) (2) PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS (LTJ) (1) SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR (MOI) (1) TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) (LTK) (1) Test, hiv detection (MZF) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750001309 Catalog Number : 6801756

Device Description : VITROS Immunodiagnostic Products PSA Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001316 Catalog Number : 6801757

Device Description : VITROS Immunodiagnostic Products CA 125 II Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LTK

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001323 Catalog Number : 6801758

Device Description : VITROS Immunodiagnostic Products CA 15-3 Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : MOI

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001415 Catalog Number : 6801812

Device Description : VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOL

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001422 Catalog Number : 6801816

Device Description : VITROS Immunodiagnostic Products Anti-HBe Reagent Pack

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001439 Catalog Number : 6801817

Device Description : VITROS Immunodiagnostic Products Anti-HBe Calibrator

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001446 Catalog Number : 6801819

Device Description : VITROS Immunodiagnostic Products HBeAg Reagent Pack

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001453 Catalog Number : 6801820

Device Description : VITROS Immunodiagnostic Products HBeAg Calibrator

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001477 Catalog Number : 6801823

Device Description : VITROS Immunodiagnostic Products HAV Total Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOL

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001521 Catalog Number : 6801861

Device Description : VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : MZF

Prescription Use : Yes

Device Count : 1

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