Duns Number:894671143
Device Description: Monoclonal Mouse Anti-Human CD30/FITC Clone Ber-H2
Catalog Number
-
Brand Name
Mono Mo A-Hu CD30/FITC Cl Ber-H2
Version/Model Number
F0849
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
ea796591-2528-45ba-8638-2909b7f46cd2
Public Version Date
December 07, 2020
Public Version Number
2
DI Record Publish Date
September 17, 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 | 490 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |
| 3 | A medical device with high risk that requires premarket approval | 5 |