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-Light - 00855574005070 Catalog Number :

Device Description : Sampling Bottles OC-Light

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Light - 00855574005094 Catalog Number :

Device Description : OC-Light Test Strips

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005100 Catalog Number :

Device Description : OC-Auto SENSOR Diana FIT Analyzer

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005117 Catalog Number :

Device Description : Latex Reagent for OC-Auto Micro 80 iFOB2 x 7 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005124 Catalog Number :

Device Description : Buffer for OC-Auto Micro 80 iFOB1 x 200 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005131 Catalog Number :

Device Description : Calibrator for OC-Auto10 x 1 mL, 2 x 45 mL Diluent

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005148 Catalog Number :

Device Description : Cuvettes for OC-Auto Micro 80 iFOB

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005155 Catalog Number :

Device Description : Wash Concentrate for OC-Auto Micro 80 iFOB1 x 120 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005162 Catalog Number :

Device Description : Buffer for OC-Auto SENSOR Diana iFOB1 x 500 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005179 Catalog Number :

Device Description : Latex Reagent for OC-Auto SENSOR Diana iFOB5 x 15 mL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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