ENTERIX INC.

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

Reagent, Occult Blood (KHE) (6)

Premarket Exempt

Clear

InSure® ONE™ - 00850093003286 Catalog Number : 11018.01

Device Description : InSure® ONE™ 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® ONE™ - 00850093003293 Catalog Number : 14103.01

Device Description : InSure® ONE™ Run Buffer - 1 Liter Bottle

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure® ONE™ - 00850093003309 Catalog Number : 90002.01

Device Description : InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 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™ - 00850093003316 Catalog Number :

Device Description : InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027 InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01)

Device Class :

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

InSure® ONE™ - 00850093003323 Catalog Number :

Device Description : InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01)

Device Class :

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

InSure® ONE™ - 00850093003354 Catalog Number : 90035.01

Device Description : InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit

Device Class : 2

Duns Number: 002224009

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

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