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) (4) System, Test, Tumor Marker, Monitoring, Bladder (MMW) (4) Reagent, Occult Blood (KHE) (2)

Premarket Exempt

Clear

OC-Auto - 00855574005186 Catalog Number :

Device Description : Wash Concentrate for OC-Auto SENSOR Diana iFOB1 x 150 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Light S - 00855574005193 Catalog Number :

Device Description : Personal Use Kit Bulk, OC-Light S

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

FOBT-CHEK - 00855574005209 Catalog Number :

Device Description : Positive Control for OC-Auto

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005216 Catalog Number :

Device Description : OC-Auto Sampling Bottles, 200 bottles

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005223 Catalog Number :

Device Description : OC-Auto Micro 80 Analyzer

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

BTA stat - 00855574005261 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

BTA stat - 00855574005278 Catalog Number :

Device Description : BTA stat Test - 5 Test kit - Hitado Labeled

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

BTA TRAK - 00855574005285 Catalog Number :

Device Description : BTA TRAK - USA Labeled

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

BTA TRAK - 00855574005292 Catalog Number :

Device Description : BTA TRAK - Internationally Labeled

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

OC-Light S - 00855574005308 Catalog Number :

Device Description : OC-Light S Test Strips

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

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