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

CALIBRATOR, PRIMARY (JIS) (4) RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE (CDP) (2) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) FERRITIN, ANTIGEN, ANTISERUM, CONTROL (DBF) (1) Multi-analyte controls, all kinds (assayed) (JJY) (1) RADIOASSAY, VITAMIN B12 (CDD) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750008476 Catalog Number : 1142561

Device Description : VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : CDD

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008506 Catalog Number : 1158864

Device Description : VITROS Immunodiagnostic Products Ferritin Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : DBF

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008551 Catalog Number : 1209733

Device Description : VITROS Immunodiagnostic Products T3 Uptake Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008728 Catalog Number : 1286293

Device Description : VITROS Immunodiagnostic Products CK-MB Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008742 Catalog Number : 1306026

Device Description : VITROS Immunodiagnostic ProductsTestosterone Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008766 Catalog Number : 1311075

Device Description : VITROS Immunodiagnostic Products Folate Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008797 Catalog Number : 1315589

Device Description : VITROS Immunodiagnostic Products Free T3 Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : CDP

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008803 Catalog Number : 1315654

Device Description : VITROS Immunodiagnostic Products Free Thyroid Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008810 Catalog Number : 1318930

Device Description : VITROS Immunodiagnostic ProductsEstradiol Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750008834 Catalog Number : 1322528

Device Description : VITROS Immunodiagnostic Products Total T3 Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : CDP

Prescription Use : Yes

Device Count : 1

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