Duns Number:078294784
Device Description: PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplification of gene PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplification of gene targets when used in combination with PCRopsis™ Reagent RVD or PCRopsis™ Reagent SRVD.
Catalog Number
783364100
Brand Name
PCRopsis
Version/Model Number
RVD Enhancer
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
2f8d462a-770d-467c-87b9-66dd53dfb6ae
Public Version Date
March 30, 2021
Public Version Number
1
DI Record Publish Date
March 22, 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 |