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) (10)

Premarket Exempt

Clear

OC-Auto - 00855574005735 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005742 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Borgess

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005759 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Beaumont Labs

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005766 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Bioreference Lab Only

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005773 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Baystate Med Center 1

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005780 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Cleveland Clinic

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005797 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Cook County

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005810 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Contra Costa Regional

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005827 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Christ Hospital Lab

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005834 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Huntington Hospital

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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