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

Single (specified) analyte controls (assayed and unassayed) (JJX) (4) CALIBRATOR, SECONDARY (JIT) (2) Test, hepatitis b (b core, be antigen, be antibody, b core igm) (LOM) (2) Multi-analyte controls unassayed (OHQ) (1) SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN (DHA) (1) Test, hiv detection (MZF) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750001538 Catalog Number : 6801862

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

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : MZF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001545 Catalog Number : 6801863

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

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : OHQ, JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001682 Catalog Number : 6801925

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 - 10758750001699 Catalog Number : 6801926

Device Description : VITROS Immunodiagnostic Products Anti-HBs Calibrator

Device Class : 3

Duns Number: 215865786

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750001972 Catalog Number : 6802093

Device Description : VITROS Immunodiagnostic Products Anti-HBs Quantitative Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002078 Catalog Number : 6802157

Device Description : VITROS Immunodiagnostic Products NT-pro BNP Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002085 Catalog Number : 6802158

Device Description : VITROS Immunodiagnostic Products NT-proBNP Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002320 Catalog Number : 6802220

Device Description : VITROS Immunodiagnostic Products Total B HCG II Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : DHA

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002337 Catalog Number : 6802221

Device Description : VITROS Immunodiagnostic Products Total B HCG II Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750002344 Catalog Number : 6802222

Device Description : VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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