PCRopsis - PCRopsis™ Reagent RVD-WHO mediates - ENTOPSIS, LLC

Duns Number:078294784

Device Description: PCRopsis™ Reagent RVD-WHO mediates extraction-free RT-qPCR of swab specimens transported i PCRopsis™ Reagent RVD-WHO mediates extraction-free RT-qPCR of swab specimens transported in WHO transport medium.

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More Product Details

Catalog Number

783946025

Brand Name

PCRopsis

Version/Model Number

Reagent RVD-WHO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2020

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJH

Product Code Name

Clinical Sample Concentrator

Device Record Status

Public Device Record Key

9cdc720b-b294-4f6b-a96a-b3e610baa1ab

Public Version Date

March 18, 2021

Public Version Number

3

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENTOPSIS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 5