PCRopsis 783100

GUDID B5507831000

PCRopsis™ Reagent RVD is an alternative to viral RNA extraction from nasopharyngeal or oropharyngeal swab samples transported in compatible transport mediums.

ENTOPSIS, LLC

Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD
Primary Device IDB5507831000
NIH Device Record Key6daf6e02-c093-4b0a-9dce-9f7e1fa99191
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCRopsis
Version Model NumberReagent RVD
Catalog Number783100
Company DUNS078294784
Company NameENTOPSIS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]
HIBCCB5507831000 [Primary]

FDA Product Code

JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [PCRopsis]

B5508880200PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transpo
B5508880050PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transpo
B5508880010PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transpo
B5507839461000PCRopsis™ Reagent RVD-WHO is an alternative to viral RNA extraction from nasopharyngeal or oro
B5507839460250PCRopsis™ Reagent RVD-WHO is an alternative to viral RNA extraction from nasopharyngeal or oro
B5507831000PCRopsis™ Reagent RVD is an alternative to viral RNA extraction from nasopharyngeal or orophar
B5507830250PCRopsis™ Reagent RVD is an alternative to viral RNA extraction from nasopharyngeal or orophar

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.