Duns Number:836976779
Device Description: Analyte specific reagent that targets the framework 3 region of the human immunoglobulin h Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy chain gene.
Catalog Number
A1010031
Brand Name
Invivoscribe
Version/Model Number
810022731574
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
8cae5c52-2e12-4239-b19d-23fb12636acc
Public Version Date
February 04, 2021
Public Version Number
4
DI Record Publish Date
October 20, 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 | 91 |
| 3 | A medical device with high risk that requires premarket approval | 2 |