Duns Number:516536641
Device Description: Anti-Human Globulin, Anti-C3d, is intended for use in the direct antiglobulin test to dete Anti-Human Globulin, Anti-C3d, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3b and/or C3d components.
Catalog Number
-
Brand Name
ALBAclone® Anti-Human Globulin Anti-C3d
Version/Model Number
Z360U
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
8dbe3e55-86a4-4ba8-a6d3-aae3862ddadb
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
February 16, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |