ORTHO CLINICAL DIAGNOSTICS

Address:1 International Business Park, The Synergy,Singapore,SG

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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) Single (specified) analyte controls (assayed and unassayed) (JJX) (2) ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS (MZO) (1) CALIBRATOR, SECONDARY (JIT) (1) ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (LFX) (1) SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER (NIG) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750002351 Catalog Number : 6802241

Device Description : VITROS Immunodiagnostic Products CA 19-9 Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : NIG

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002368 Catalog Number : 6802242

Device Description : VITROS Immunodiagnostic Products CA 19-9™ Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002511 Catalog Number : 6802302

Device Description : VITROS Immunodiagnostic Products Troponin I ES Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002528 Catalog Number : 6802303

Device Description : VITROS Immunodiagnostic Products Troponin I ES Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002764 Catalog Number : 6802450

Device Description : VITROS Immunodiagnostic Products HBsAg Reagent Pack

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002771 Catalog Number : 6802451

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 - 10758750002788 Catalog Number : 6802452

Device Description : VITROS Immunodiagnostic Products Anti-HBs Reagent Pack

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002795 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 - 10758750002801 Catalog Number : 6802454

Device Description : VITROS Immunodiagnostic Products Anti-HCV Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : MZO

Prescription Use : Yes

Device Count : 1

VITROS - 10758750004546 Catalog Number : 8209074

Device Description : VITROS Immunodiagnostic Products Rubella IgG Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LFX

Prescription Use : Yes

Device Count : 1

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