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) (1) COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE (JMM) (1) FLUOROMETRIC METHOD, CPK OR ISOENZYMES (JHX) (1) PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS (LTJ) (1) RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE (CGJ) (1) RADIOIMMUNOASSAY, FREE THYROXINE (CEC) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1) RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) (CFT) (1) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (1) SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN (DHX) (1)

Premarket Exempt

No Yes

Clear

VITROS - 10758750000029 Catalog Number : 1728872

Device Description : VITROS Immunodiagnostic Products Free T4 Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : CEC

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000111 Catalog Number : 1849793

Device Description : VITROS Immunodiagnostic Products Prolactin Reagent Pack

Device Class : 1

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : CFT

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000203 Catalog Number : 1896836

Device Description : VITROS Immunodiagnostic Products CK-MB Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JHX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000210 Catalog Number : 1901263

Device Description : VITROS Immunodiagnostic ProductsFSH Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JIS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000227 Catalog Number : 1912997

Device Description : VITROS Immunodiagnostic Products TSH Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000258 Catalog Number : 1920115

Device Description : VITROS Immunodiagnostic Products CEA Reagent Pack

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : DHX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000302 Catalog Number : 1931922

Device Description : VITROS Immunodiagnostic Products FSH Reagent Pack

Device Class : 1

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : CGJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000319 Catalog Number : 1933027

Device Description : VITROS Immunodiagnostic Products PSA Calibrators

Device Class : 2

Duns Number: 215865786

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000333 Catalog Number : 1938570

Device Description : VITROS Immunodiagnostic Products Progesterone Reagent Pack

Device Class : 1

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000500 Catalog Number : 6800030

Device Description : VITROS Immunodiagnostic Products NTx Reagent Pack

Device Class : 1

Duns Number: 215865786

Premarket Exempt : Yes

Product Code : JMM

Prescription Use : Yes

Device Count : 1

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