Duns Number:003255213
Device Description: IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (D IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
Catalog Number
-
Brand Name
Control Cells
Version/Model Number
510400/510402
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)
Yes
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
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
4606e578-29d6-4c56-8e44-99307c84b0c1
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 21, 2016
Package DI Number
20858400005095
Quantity per Package
10
Contains DI Package
00858400005091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |