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 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 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 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]

FDA Product Code

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
B550888100158PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating t
B55088800003PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating t
B55078335000PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, wit
B55078331000PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, wit
B55078330250PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, wit
B55078310000PCRopsis™ Reagent RVD mediates extraction-free RT-qPCR of swab specimens transported in compat
B5507833641000PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplification of gene targ
B5507833640100PCRopsis™ RVD Enhancer is intended to enhance PCR-mediated amplification of gene targets when
B550778310000PCRopsis™ Reagent SRVD (1000 mL) mediates extraction-free RT-qPCR from specimens in saliva.
B55077831000PCRopsis™ Reagent SRVD (100 mL) mediates extraction-free RT-qPCR from specimens in saliva.
B55077830250PCRopsis™ Reagent SRVD (25 mL) mediates extraction-free RT-qPCR from specimens in saliva.
B5502825000PCRopsis™ Reagent Buccal (500 mL) mediates extraction-free PCR from buccal specimens directly
B55028210000PCRopsis™ Reagent Buccal (1,000 mL) mediates extraction-free PCR from buccal specimens directl
B5502821000PCRopsis™ Reagent Buccal (100 mL) mediates extraction-free PCR from buccal specimens directly
B5502820250PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens directly f
B5507837810000PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab s
B550783781000PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab sp
B550783780250PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab spe
B55026685036PCRopsis™ Concentrator (50 pre-loaded tubes) concentrates clinical samples.
B550266825047PCRopsis™ Concentrator (250 pre-loaded tubes) concentrates clinical samples.
B550227610000PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from w
B55022761000PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from wh
B55022760100PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from who
B5507870010PCRopsis™ Support helps mediate select Next Gen Direct PCR™ applications (e.g., PCR amplific
B5503585000PCRopsis™ Elution Buffer is intended to elute test material from substrates.
B55035810000PCRopsis™ Elution Buffer is intended to elute test material from substrates.
B5503581000PCRopsis™ Elution Buffer is intended to elute test material from substrates.
B5503580250PCRopsis™ Elution Buffer is intended to elute test material from substrates
B5502280010PCRopsis™ Activator helps mediate room temperature Next Gen Direct PCR™
B5507833610000PCRopsis™ Reagent RVD with RVD Enhancer (1 L) mediates extraction-free RT-qPCR of various spec
B550783361000PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPCR of various s
B550783360250PCRopsis™ Reagent RVD with RVD Enhancer (25 mL) mediates extraction-free RT-qPCR of various sp
B55059785036PCRopsis™ Lysis Beads (50 pre-loaded tubes) facilitate lysis of difficult to lyse microorganis
B5507870020PCRopsis™ Support (0.25 mL) helps mediate select Next Gen Direct PCR™ applications (e.g., PC
B55059725046PCRopsis™ Lysis Beads (250 pre-loaded tubes) facilitate lysis of difficult to lyse microorgani
B55059700250PCRopsis™ Lysis Beads (25 grams, bulk) facilitate lysis of difficult to lyse microorganisms.
B55059705000PCRopsis™ Lysis Beads (500 grams, bulk) facilitate lysis of difficult to lyse microorganisms.
B5502280250PCRopsis™ Activator (25 mL) helps mediate room temperature Next Gen Direct PCR™
B55059725000PCRopsis™ Lysis Beads (2.5 kilograms, bulk) facilitate lysis of difficult to lyse microorganis
B55059710000PCRopsis™ Lysis Beads (1 kilogram, bulk) facilitate lysis of difficult to lyse microorganisms.
B5507870040PCRopsis™ Support (500 uL) helps mediate select Next Gen Direct PCR™ applications (e.g., PCR
B55059700100PCRopsis™ Lysis Beads (10 grams, bulk) facilitate lysis of difficult to lyse microorganisms.
B55087810000PCRopsis™ UrineA (1 mL) improves the functionality of PCRopsis™ Reagent 123, especially when

Trademark Results [PCRopsis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PCROPSIS
PCROPSIS
87891197 5641569 Live/Registered
Entopsis LLC
2018-04-24

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