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) (8) System, Test, Tumor Marker, Monitoring, Bladder (MMW) (2)

Premarket Exempt

Clear

OC-Auto - 00855574005612 Catalog Number :

Device Description : OC-Auto Micro 80 Analyzer, Refurbished

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

BTA stat - 00855574005629 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

BTA stat - 00855574005636 Catalog Number :

Device Description : BTA stat Test - 30 Test kit - USA Labeled

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : MMW

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005643 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005650 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for ACL Rosemont IL

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005674 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005698 Catalog Number :

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

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005704 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Adventist Medical Center

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005711 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Aesculapian-InterCoasta

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005728 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Family Practice Phy

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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