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.
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
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
JJH
Product Code Name
Clinical Sample Concentrator
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
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 |