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-Auto - 00816917025605 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Trident Labs

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025612 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025629 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Dynacare, Somagen

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025636 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025650 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025667 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Innovative Health Diagnostics

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025674 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Light S - 00816917025681 Catalog Number :

Device Description : Personal Use Kit OC-Light S, for Emanate Health Inter-Comm Hospital

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025698 Catalog Number :

Device Description : OC-Auto Sampling Bottles for Brazil, 1000 bottles

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Light S - 00816917025704 Catalog Number :

Device Description : Personal Use Kit OC-Light S, for Missouri Baptist Med Ctr

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

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