Duns Number:836976779
Device Description: Analyte Specific Reagent that targets the framework 1 region of the human immunoglobulin h Analyte Specific Reagent that targets the framework 1 region of the human immunoglobulin heavy chain gene.
Catalog Number
A1010010
Brand Name
Invivoscribe
Version/Model Number
810022731536
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 05, 2021
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
85cac99d-bbf5-46f5-bfcb-2afd886fff61
Public Version Date
March 09, 2022
Public Version Number
5
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 |