PCRopsis - PCRopsis™ Reagent RVD-E mediates extraction-free - ENTOPSIS, LLC

Duns Number:078294784

Device Description: PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, PCRopsis™ Reagent RVD-E mediates extraction-free RT-qPCR of specimens directly from swabs, without the need for transport medium.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

7833500

Brand Name

PCRopsis

Version/Model Number

Reagent RVD-E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

fc6dea29-5ffd-40fa-82ab-4e7cac74e90a

Public Version Date

January 06, 2021

Public Version Number

1

DI Record Publish Date

December 29, 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