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

Calibrator, primary (JIS) (2) Reagent, coronavirus serological (QKO) (2) KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER (LOJ) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750034413 Catalog Number : 6199960

Device Description : VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack

Device Class :

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750034420 Catalog Number : 6199961

Device Description : VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator

Device Class :

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750034659 Catalog Number : 6199330

Device Description : VITROS Immunodiagnostic ProductsProlactin Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750034819 Catalog Number : 6177745

Device Description : VITROS Immunodiagnostic Products AFP Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750034895 Catalog Number : 6177750

Device Description : VITROS Immunodiagnostic ProductsAFP Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : JIS

Prescription Use : Yes

Device Count : 1

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