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) (6) CALIBRATOR, SECONDARY (JIT) (1) COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE (JMM) (1) SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR (MOI) (1) TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) (LTK) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750000517 Catalog Number : 6800031

Device Description : VITROS Immunodiagnostic Products NTx Calibrators

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JMM

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000531 Catalog Number : 6800033

Device Description : VITROS Immunodiagnostic Products CA 15-3 Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : MOI

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000548 Catalog Number : 6800034

Device Description : VITROS Immunodiagnostic Products CA 125 II Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LTK

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000555 Catalog Number : 6800035

Device Description : VITROS Immunodiagnostic Products CA 19-9 Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000661 Catalog Number : 6800336

Device Description : VITROS Immunodiagnostic Products NTx Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000692 Catalog Number : 6800366

Device Description : VITROS Immunodiagnostic Products TSH Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000708 Catalog Number : 6800367

Device Description : VITROS Immunodiagnostic Products Total T4 Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000715 Catalog Number : 6800368

Device Description : VITROS Immunodiagnostic Products Total T3 Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000722 Catalog Number : 6800369

Device Description : VITROS Immunodiagnostic Products Free T4 Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000739 Catalog Number : 6800370

Device Description : VITROS Immunodiagnostic Products Free T3 Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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