Duns Number:061446282
Device Description: Weak D Cells are used for quality control of weak D testing. Weak D Cells are a suspension Weak D Cells are used for quality control of weak D testing. Weak D Cells are a suspension of selected weak D red blood cells. This product is a one (1) vial configuration.
Catalog Number
0002995
Brand Name
Weak D Cells
Version/Model Number
0002995
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)
Yes
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
75eb5f21-000e-44db-b8b6-047e6ee2accc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 15, 2016
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |