FDA.reportPublic FDA data

PCRopsis

Primary DI
B5508880010
Brand
PCRopsis
Company
ENTOPSIS, LLC
Model
Universal Viral Transport
Catalog number
888001
Device description
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
Published
2020-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5508880010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Viral transport medium IVDA vessel containing transport medium intended to be used for the preservation and transport of viral culture isolates from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078294784
Device count
1
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
B5502668503PCRopsisConcentrator2668502021-05-13
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16973471962263BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
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38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011710UriSponge™COPAN ITALIA SPAJSM2025-03-12
38053326011598UTM®COPAN ITALIA SPAJSM2024-11-13
38053326011604UTM® COPAN ITALIA SPAJSM2024-11-13
38053326011611UTM® COPAN ITALIA SPAJSM2024-11-13
00816576026067TransPROHARDY DIAGNOSTICSJSM2024-10-08
16977644780029BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780036BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780043BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780012BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-12
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