ORTHO CLINICAL DIAGNOSTICS

Address:7200 NW 19th Street Suite 401,Miami,FL,33126,US

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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) (10)

Premarket Exempt

No Yes

Clear

VITROS - 10758750000746 Catalog Number : 6800371

Device Description : VITROS Immunodiagnostic Products T3 Uptake Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000753 Catalog Number : 6800372

Device Description : VITROS Immunodiagnostic Products LH Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000760 Catalog Number : 6800373

Device Description : VITROS Immunodiagnostic Products FSH Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000777 Catalog Number : 6800374

Device Description : VITROS Immunodiagnostic Products Prolactin Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000784 Catalog Number : 6800375

Device Description : VITROS Immunodiagnostic Products Progesterone Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000791 Catalog Number : 6800377

Device Description : VITROS Immunodiagnostic Products CK-MB Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000807 Catalog Number : 6800378

Device Description : VITROS Immunodiagnostic Products Ferritin Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000814 Catalog Number : 6800380

Device Description : VITROS Immunodiagnostic Products Estradiol Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000838 Catalog Number : 6800660

Device Description : VITROS Immunodiagnostic Products Testosterone Controls

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

VITROS - 10758750000845 Catalog Number : 6800661

Device Description : VITROS Immunodiagnostic Products Testosterone Range Verifiers

Device Class : 1

Duns Number: 215865786

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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