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

Clinical Sample Concentrator (JJH) (10)

Premarket Exempt

Yes

Clear

PCRopsis - B5502825000 Catalog Number : 282500

Device Description : PCRopsis™ Reagent Buccal (500 mL) mediates extraction-free PCR from buccal speci PCRopsis™ Reagent Buccal (500 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5503580250 Catalog Number : 358025

Device Description : PCRopsis™ Elution Buffer is intended to elute test material from substrates

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5503581000 Catalog Number : 358100

Device Description : PCRopsis™ Elution Buffer is intended to elute test material from substrates.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55035810000 Catalog Number : 3581000

Device Description : PCRopsis™ Elution Buffer is intended to elute test material from substrates.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5503585000 Catalog Number : 358500

Device Description : PCRopsis™ Elution Buffer is intended to elute test material from substrates.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55059700250 Catalog Number : 5970025

Device Description : PCRopsis™ Lysis Beads (25 grams, bulk) facilitate lysis of difficult to lyse mic PCRopsis™ Lysis Beads (25 grams, bulk) facilitate lysis of difficult to lyse microorganisms.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55059705000 Catalog Number : 5970500

Device Description : PCRopsis™ Lysis Beads (500 grams, bulk) facilitate lysis of difficult to lyse mi PCRopsis™ Lysis Beads (500 grams, bulk) facilitate lysis of difficult to lyse microorganisms.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55059710000 Catalog Number : 5971000

Device Description : PCRopsis™ Lysis Beads (1 kilogram, bulk) facilitate lysis of difficult to lyse m PCRopsis™ Lysis Beads (1 kilogram, bulk) facilitate lysis of difficult to lyse microorganisms.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55059725000 Catalog Number : 5972500

Device Description : PCRopsis™ Lysis Beads (2.5 kilograms, bulk) facilitate lysis of difficult to lys PCRopsis™ Lysis Beads (2.5 kilograms, bulk) facilitate lysis of difficult to lyse microorganisms.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5505972504 Catalog Number : 597250

Device Description : PCRopsis™ Lysis Beads (250 pre-loaded tubes) facilitate lysis of difficult to ly PCRopsis™ Lysis Beads (250 pre-loaded tubes) facilitate lysis of difficult to lyse microorganisms.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 250

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