FDA.reportPublic FDA data

PCRopsis

Primary DI
B5502668503
Brand
PCRopsis
Company
ENTOPSIS, LLC
Model
Concentrator
Catalog number
266850
Device description
PCRopsis™ Concentrator (50 pre-loaded tubes) concentrates clinical samples.
Published
2021-05-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5502668503PrimaryHIBCC0
B55026685036Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Evaporation/filtration sample concentratorA mains electricity (AC-powered) laboratory device designed to concentrate fluid containing solutes (dissolved substances, including salts and proteins/hormones) or other chemical compounds (drugs or toxins) by removing the water element. It typically uses heat (to encourage evaporation), membranes, or other small-pore filters that only enable the transmission of water (either by osmotic transfer or sheer physical size of the compounds, with or without the assistance of added pressure via a pump or vacuum) to reduce the fluid component. Some types may employ low pressure gas distributed via a manifold that is blown onto the fluid surface of the solution (to encourage solvent evaporation).

Regulatory Flags#

DUNS number
078294784
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5502280250PCRopsisActivator2280252022-06-10
B550783360010PCRopsisReagent RVD with RVD Enhancer783360012024-04-11
B55026682504PCRopsisConcentrator26682502021-05-13
B550ENT0010OpsisDxNuTec ChamberENT0012021-08-26
B550ENT0020OpsisDxSignal EnhancerENT0022021-08-26
B550ENT0040OpsisDxStandard MediaENT0042021-08-26
B550ENT0070OpsisDxTesting TrayENT0072021-08-26
B550ENT0100OpsisDxQuality Control TrayENT0102021-08-26
B5502280010PCRopsisActivator2280012021-08-24
B5503580250PCRopsisElution Buffer3580252021-08-24
B5503581000PCRopsisElution Buffer3581002021-08-24
B55022760100PCRopsisBCS Nano22760102021-06-08
B55022761000PCRopsisBCS Nano22761002021-06-08
B550227610000PCRopsisBCS Nano227610002021-06-08
B550783780250PCRopsisReagent RVD-RT783780252021-05-12
B550783781000PCRopsisReagent RVD-RT783781002021-05-12
B5507837810000PCRopsisReagent RVD-RT7837810002021-05-12
B5502820250PCRopsisReagent Buccal2820252021-04-19
B5502821000PCRopsisReagent Buccal2821002021-04-19
B55028210000PCRopsisReagent Buccal28210002021-04-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
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04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
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04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
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