Duns Number:078294784
Device Description: PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens direct PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for transport medium.
Catalog Number
282025
Brand Name
PCRopsis
Version/Model Number
Reagent Buccal
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
cea6afc3-b675-4ef1-9f01-a288cd0cdc07
Public Version Date
April 27, 2021
Public Version Number
1
DI Record Publish Date
April 19, 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 |