ENTOPSIS, LLC

PCRopsis - B5505978503 Catalog Number : 597850

Device Description : PCRopsis™ Lysis Beads (50 pre-loaded tubes) facilitate lysis of difficult to lys PCRopsis™ Lysis Beads (50 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 : 50

PCRopsis - B55077830250 Catalog Number : 7783025

Device Description : PCRopsis™ Reagent SRVD (25 mL) mediates extraction-free RT-qPCR from specimens in saliva.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55077831000 Catalog Number : 7783100

Device Description : PCRopsis™ Reagent SRVD (100 mL) mediates extraction-free RT-qPCR from specimens in saliva.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B550778310000 Catalog Number : 77831000

Device Description : PCRopsis™ Reagent SRVD (1000 mL) mediates extraction-free RT-qPCR from specimens PCRopsis™ Reagent SRVD (1000 mL) mediates extraction-free RT-qPCR from specimens in saliva.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507830250 Catalog Number : 783025

Device Description : PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B5507831000 Catalog Number : 783100

Device Description : PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55078310000 Catalog Number : 7831000

Device Description : PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.

Device Class : 1

Duns Number: 078294784

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

PCRopsis - B55078330250 Catalog Number : 7833025

Device Description : PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly f PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of 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 - B55078331000 Catalog Number : 7833100

Device Description : PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly f PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of 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 - B55078335000 Catalog Number : 7833500

Device Description : PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly f PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of 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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