PCRopsis 78336025

GUDID B550783360250

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

ENTOPSIS, LLC

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: B550783360250
• NIH Device Record Key: f12c8f0b-2319-4ca3-a16a-1b9630a55847
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCRopsis
• Version Model Number: Reagent RVD with RVD Enhancer
• Catalog Number: 78336025
• Company DUNS: 078294784
• Company Name: ENTOPSIS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B550783360250 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-13
• Device Publish Date: 2022-05-05

On-Brand Devices [PCRopsis]

• B5508880200: PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transpo
• B5508880050: PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transpo
• B5508880010: PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transpo
• B5507839461000: PCRopsis™ Reagent RVD-WHO is an alternative to viral RNA extraction from nasopharyngeal or oro
• B5507839460250: PCRopsis™ Reagent RVD-WHO is an alternative to viral RNA extraction from nasopharyngeal or oro
• B5507831000: PCRopsis™ Reagent RVD is an alternative to viral RNA extraction from nasopharyngeal or orophar
• B5507830250: PCRopsis™ Reagent RVD is an alternative to viral RNA extraction from nasopharyngeal or orophar
• B550888100158: PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating t
• B55088800003: PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating t
• B55078335000: PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, wit
• B55078331000: PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, wit
• B55078330250: PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, wit
• B55078310000: PCRopsis™ Reagent RVD mediates extraction-free RT-qPCR of swab specimens transported in compat
• B5507833641000: PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplification of gene targ
• B5507833640100: PCRopsis™ RVD Enhancer is intended to enhance PCR-mediated amplification of gene targets when
• B550778310000: PCRopsis™ Reagent SRVD (1000 mL) mediates extraction-free RT-qPCR from specimens in saliva.
• B55077831000: PCRopsis™ Reagent SRVD (100 mL) mediates extraction-free RT-qPCR from specimens in saliva.
• B55077830250: PCRopsis™ Reagent SRVD (25 mL) mediates extraction-free RT-qPCR from specimens in saliva.
• B5502825000: PCRopsis™ Reagent Buccal (500 mL) mediates extraction-free PCR from buccal specimens directly
• B55028210000: PCRopsis™ Reagent Buccal (1,000 mL) mediates extraction-free PCR from buccal specimens directl
• B5502821000: PCRopsis™ Reagent Buccal (100 mL) mediates extraction-free PCR from buccal specimens directly
• B5502820250: PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens directly f
• B5507837810000: PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab s
• B550783781000: PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab sp
• B550783780250: PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab spe
• B55026685036: PCRopsis™ Concentrator (50 pre-loaded tubes) concentrates clinical samples.
• B550266825047: PCRopsis™ Concentrator (250 pre-loaded tubes) concentrates clinical samples.
• B550227610000: PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from w
• B55022761000: PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from wh
• B55022760100: PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from who
• B5507870010: PCRopsis™ Support helps mediate select Next Gen Direct PCR™ applications (e.g., PCR amplific
• B5503585000: PCRopsis™ Elution Buffer is intended to elute test material from substrates.
• B55035810000: PCRopsis™ Elution Buffer is intended to elute test material from substrates.
• B5503581000: PCRopsis™ Elution Buffer is intended to elute test material from substrates.
• B5503580250: PCRopsis™ Elution Buffer is intended to elute test material from substrates
• B5502280010: PCRopsis™ Activator helps mediate room temperature Next Gen Direct PCR™
• B5507833610000: PCRopsis™ Reagent RVD with RVD Enhancer (1 L) mediates extraction-free RT-qPCR of various spec
• B550783361000: PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPCR of various s
• B550783360250: PCRopsis™ Reagent RVD with RVD Enhancer (25 mL) mediates extraction-free RT-qPCR of various sp
• B55059785036: PCRopsis™ Lysis Beads (50 pre-loaded tubes) facilitate lysis of difficult to lyse microorganis
• B5507870020: PCRopsis™ Support (0.25 mL) helps mediate select Next Gen Direct PCR™ applications (e.g., PC
• B55059725046: PCRopsis™ Lysis Beads (250 pre-loaded tubes) facilitate lysis of difficult to lyse microorgani
• B55059700250: PCRopsis™ Lysis Beads (25 grams, bulk) facilitate lysis of difficult to lyse microorganisms.
• B55059705000: PCRopsis™ Lysis Beads (500 grams, bulk) facilitate lysis of difficult to lyse microorganisms.
• B5502280250: PCRopsis™ Activator (25 mL) helps mediate room temperature Next Gen Direct PCR™
• B55059725000: PCRopsis™ Lysis Beads (2.5 kilograms, bulk) facilitate lysis of difficult to lyse microorganis
• B55059710000: PCRopsis™ Lysis Beads (1 kilogram, bulk) facilitate lysis of difficult to lyse microorganisms.
• B5507870040: PCRopsis™ Support (500 uL) helps mediate select Next Gen Direct PCR™ applications (e.g., PCR
• B55059700100: PCRopsis™ Lysis Beads (10 grams, bulk) facilitate lysis of difficult to lyse microorganisms.
• B55087810000: PCRopsis™ UrineA (1 mL) improves the functionality of PCRopsis™ Reagent 123, especially when