Duns Number:078294784
Device Description: PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.
Catalog Number
7831000
Brand Name
PCRopsis
Version/Model Number
Reagent RVD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2022
Issuing Agency
In HIBCC
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJH
Product Code Name
Clinical Sample Concentrator
Public Device Record Key
fa3cac8d-d3d3-494a-9879-0903399fa1fa
Public Version Date
May 06, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |