Duns Number:312576506
Device Description: For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3 For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)
Catalog Number
-
Brand Name
IH-Internal QC
Version/Model Number
814172100
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
Yes
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
BK170064
Product Code
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
ab40f444-8c92-4850-92ec-8231eee897c6
Public Version Date
March 14, 2022
Public Version Number
4
DI Record Publish Date
April 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| U | Unclassified | 21 |