ENTOPSIS, LLC

ENTOPSIS, LLC

Address:7600 NW 69th Ave,Medley,FL,33166,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

Instrumentation For Clinical Multiplex Test Systems (NSU) (2)

Premarket Exempt

Yes

Clear

OpsisDx - B550ENT0070 Catalog Number : ENT007

Device Description : Metal tray used to heat OpsisDx NuTec Slides

Device Class : 2

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : No

Device Count : 1

OpsisDx - B550ENT0100 Catalog Number : ENT010

Device Description : Metal tray used for quality control of OpsisDx heater

Device Class : 2

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : No

Device Count : 1

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