ENTERIX INC.

Address:236 Fernwood Ave,EDISON,NJ,08837,US

Want to know more about this Organization? Request more information now!

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

Reagent, Occult Blood (KHE) (9) Control, Fecal Occult Blood (OSL) (1)

Premarket Exempt

Clear

InSure FIT - 00850093003019 Catalog Number : 80025

Device Description : InSure FIT Developer Kit

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure FIT - 00850093003033 Catalog Number : 16800

Device Description : InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control ( InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each)

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : OSL

Prescription Use : No

Device Count : 1

InSure FIT - 00850093003040 Catalog Number :

Device Description : InSure FIT Combo Pack

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

InSure FIT - 00850093003064 Catalog Number : 15022

Device Description : InSure FIT Kit

Device Class :

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

InSure FIT - 00850093003071 Catalog Number : 11018

Device Description : InSure FIT Test Cards for QC - 50 pack

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure FIT - 00850093003088 Catalog Number :

Device Description : InSure FIT Test Strip

Device Class :

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure FIT - 00850093003095 Catalog Number : 14103

Device Description : InSure FIT Run Buffer - 1 Liter Bottle

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure FIT - 00850093003187 Catalog Number : 90002

Device Description : InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test S InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test Strips, and 1 Run Buffer Bottle

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure® ONE™ - 00850093003231 Catalog Number : 80025.01

Device Description : InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run Buffer (9mL)

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure® ONE™ - 00850093003279 Catalog Number : 90030.01

Device Description : InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

Previous 1 2 Next