Duns Number:089855696
Device Description: The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instr The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from FFPE (formalin fixed, paraffin embedded) tissue samples.
Catalog Number
AS1360
Brand Name
Maxwell® CSC RNA FFPE Kit
Version/Model Number
AS1360
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
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
e6628f62-b568-4242-83b7-10024693df71
Public Version Date
February 09, 2022
Public Version Number
1
DI Record Publish Date
February 01, 2022
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |