ORTHO-CLINICAL DIAGNOSTICS, INC.

Address:6005 Freeport Avenue, Suite 130,Memphis,TN,38141,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

Coronavirus antigen detection test system. (QKP) (2) Reagent, coronavirus serological (QKO) (2)

Premarket Exempt

No Yes

Clear

VITROS - 10758750033584 Catalog Number : 6199949

Device Description : VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack

Device Class :

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : Yes

Device Count : 1

VITROS - 10758750033591 Catalog Number : 6199950

Device Description : VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator

Device Class :

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : Yes

Device Count : 1

VITROS - 10758750034567 Catalog Number : 6199975

Device Description : VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack

Device Class :

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750034581 Catalog Number : 6199976

Device Description : VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators

Device Class :

Duns Number: 623873044

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

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