Duns Number:143647035
Device Description: Hemo-QC simulates blood samples and is intended for the daily quality control of routine b Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
Catalog Number
H9200
Brand Name
Hemo-QC
Version/Model Number
H9200
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)
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
72b83b54-52d3-4141-a154-14c48d92c92d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 20, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |