Duns Number:836976779
Device Description: This analyte specific reagent targets the NPM1 gene in Exon 12
Catalog Number
A4160001
Brand Name
Invivoscribe
Version/Model Number
810022731824
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
-
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
3d5de7e7-80ff-44cf-a99f-749d4041ea9c
Public Version Date
January 28, 2022
Public Version Number
1
DI Record Publish Date
January 20, 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 | 91 |
| 3 | A medical device with high risk that requires premarket approval | 2 |