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) (7) Reagent, Occult Blood (KHE) (2) System, Test, Tumor Marker, Monitoring, Bladder (MMW) (1)

Premarket Exempt

Clear

OC-Auto - 00816917025810 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for UC Davis Health

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025827 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Washington Health System

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025841 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for VA Omaha, NE

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025858 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Providence Covenant Health

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025865 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for LabCorp Dallas, TX

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025872 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Main Line Health

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

BTA stat - 00855574005001 Catalog Number :

Device Description : BTA stat Test - 10 Test kit - Hitado Labeled

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005018 Catalog Number :

Device Description : OC-Auto Personal Use Kit

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Light - 00855574005056 Catalog Number :

Device Description : Starter Pack OC-Light

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Light - 00855574005063 Catalog Number :

Device Description : OC-Light Test Kit

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

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