POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Address:510 FURNACE DOCK RD.,CORTLANDT MANOR,NY,10567,US

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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

Automated Occult Blood Analyzer (OOX) (8) Reagent, Occult Blood (KHE) (2)

Premarket Exempt

Clear

OC-Light S - 00816917025506 Catalog Number :

Device Description : Personal Use Kit OC-Light S, for Monument Health

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025513 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for University of Missouri

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025520 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Sanford USD Medical Center

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025537 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Gundersen Boscobel Area Hosp and Clinics Lab

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025544 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Sharp Rees Stealy

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025551 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Grady Health System

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025568 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Duke Health Holly Springs

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025575 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Harbin Clinic

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Light S - 00816917025582 Catalog Number :

Device Description : Personal Use Kit OC-Light S, for Goshen Health

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025599 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Wellspan Lab Services

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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