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

Single (specified) analyte controls (assayed and unassayed) (JJX) (4) Test, hepatitis b (b core, be antigen, be antibody, b core igm) (LOM) (4) Hepatitis a test (antibody and igm antibody) (LOL) (1) Kit, serological, positive control (MJX) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750001149 Catalog Number : 6801390

Device Description : VITROS Immunodiagnostic Products HBsAg Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : MJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001156 Catalog Number : 6801421

Device Description : VITROS Immunodiagnostic Products Anti-HCV Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001187 Catalog Number : 6801425

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

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001194 Catalog Number : 6801426

Device Description : VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001200 Catalog Number : 6801427

Device Description : VITROS Immunodiagnostic Products Anti-HBc IgM Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001217 Catalog Number : 6801428

Device Description : VITROS Immunodiagnostic Products Anti-HBc Reagent Pack

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001224 Catalog Number : 6801429

Device Description : VITROS Immunodiagnostic Products Anti-HBc Calibrator

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001231 Catalog Number : 6801430

Device Description : VITROS Immunodiagnostic Products Anti-HBc Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001286 Catalog Number : 6801462

Device Description : VITROS Immunodiagnostic Products Anti-HAV Total Calibrator

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOL

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001293 Catalog Number : 6801463

Device Description : VITROS Immunodiagnostic Products Anti-HAV Total Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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