Duns Number:066761271
Device Description: George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas d George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived from non-medicated, non-smoking donors between the ages of 18 and 65 years of age. The kit is intended for use in establishing controlling reference ranges for coagulation assays.
Catalog Number
-
Brand Name
George King SDN Control Kit
Version/Model Number
0075-20
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
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
-
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
90449a1d-4f58-43ea-bcec-da11693ded53
Public Version Date
November 26, 2019
Public Version Number
1
DI Record Publish Date
November 18, 2019
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. | 120 |