POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

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

Automated Occult Blood Analyzer (OOX) (5) Reagent, Occult Blood (KHE) (4) System, Test, Tumor Marker, Monitoring, Bladder (MMW) (1)

Premarket Exempt

Clear

OC-Light S - 00855574005315 Catalog Number :

Device Description : Sampling Bottles OC-Light S

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Light S - 00855574005322 Catalog Number :

Device Description : Test Kit OC-Light S

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Light S - 00855574005339 Catalog Number :

Device Description : Starter Pack OC-Light S

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Light S - 00855574005346 Catalog Number :

Device Description : Personal Use Kit OC-Light S

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

BTA stat - 00855574005353 Catalog Number :

Device Description : BTA stat - Controls - US Labeled15 Deteriminations

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

FOBT-CHEK - 00855574005520 Catalog Number :

Device Description : Negative Control for OC-Auto

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005544 Catalog Number :

Device Description : Latex Reagent for OC-Auto Micro 80 iFOB2 x 4 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005568 Catalog Number :

Device Description : OC-Auto Sampling Bottles, 1000 bottles

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005575 Catalog Number :

Device Description : OC-Auto Sampling Bottles, 1000 bottles New Brunswick/Quebec

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005582 Catalog Number :

Device Description : OC-Auto Sampling Bottles, 1000 bottles, Alberta

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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