ENTOPSIS, LLC

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

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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 - B55022760100 Catalog Number : 2276010

Device Description : PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55022761000 Catalog Number : 2276100

Device Description : PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B550227610000 Catalog Number : 22761000

Device Description : PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red bloo PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5502280010 Catalog Number : 228001

Device Description : PCRopsis™ Activator helps mediate room temperature Next Gen Direct PCR™

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5502280250 Catalog Number : 228025

Device Description : PCRopsis™ Activator (25 mL) helps mediate room temperature Next Gen Direct PCR™

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55026682504 Catalog Number : 2668250

Device Description : PCRopsis™ Concentrator (250 pre-loaded tubes) concentrates clinical samples.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 250

PCRopsis - B5502668503 Catalog Number : 266850

Device Description : PCRopsis™ Concentrator (50 pre-loaded tubes) concentrates clinical samples.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 50

PCRopsis - B5502820250 Catalog Number : 282025

Device Description : PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specim PCRopsis™ Reagent Buccal (25 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 - B5502821000 Catalog Number : 282100

Device Description : PCRopsis™ Reagent Buccal (100 mL) mediates extraction-free PCR from buccal speci PCRopsis™ Reagent Buccal (100 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 - B55028210000 Catalog Number : 2821000

Device Description : PCRopsis™ Reagent Buccal (1,000 mL) mediates extraction-free PCR from buccal spe PCRopsis™ Reagent Buccal (1,000 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

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