Duns Number:003255213
Device Description: Blood Bank kit used to perform quality control testing of reverse grouping and screening c Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells.
Catalog Number
-
Brand Name
DailyChek QC Kit
Version/Model Number
510395
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
BK120042
Product Code
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
47dc9566-5d5c-4f0e-9550-8d468d166625
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |