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

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PCRopsis - B550783360250 Catalog Number : 78336025

Device Description : PCRopsis™ Reagent RVD with RVD Enhancer (25 mL) mediates extraction-free RT-qPCR PCRopsis™ Reagent RVD with RVD Enhancer (25 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B550783361000 Catalog Number : 78336100

Device Description : PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPC PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507833610000 Catalog Number : 783361000

Device Description : PCRopsis™ Reagent RVD with RVD Enhancer (1 L) mediates extraction-free RT-qPCR o PCRopsis™ Reagent RVD with RVD Enhancer (1 L) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507833640100 Catalog Number : 783364010

Device Description : PCRopsis™ RVD Enhancer is intended to enhance PCR-mediated amplification of gene PCRopsis™ RVD Enhancer is intended to enhance PCR-mediated amplification of gene targets when used in combination with PCRopsis™ Reagent RVD or PCRopsis™ Reagent SRVD.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507833641000 Catalog Number : 783364100

Device Description : PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplificatio PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplification of gene targets when used in combination with PCRopsis™ Reagent RVD or PCRopsis™ Reagent SRVD.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B550783780250 Catalog Number : 78378025

Device Description : PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B550783781000 Catalog Number : 78378100

Device Description : PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urin PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507837810000 Catalog Number : 783781000

Device Description : PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, uri PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507839460250 Catalog Number : 783946025

Device Description : PCRopsis™ Reagent RVD-WHO mediates extraction-free RT-qPCR of swab specimens tra PCRopsis™ Reagent RVD-WHO mediates extraction-free RT-qPCR of swab specimens transported in WHO transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507839461000 Catalog Number : 783946025

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

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