Duns Number:066761271
Device Description: George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma d George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived from non-mediated, non-smoking donors between the ages of 18-56 years of age. The kit contains 25 males and 25 females and is intended for use in establishing reference ranges for coagulation assays.
Catalog Number
-
Brand Name
George King CORE Kit
Version/Model Number
0070-50
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
e687655e-be51-4344-ab47-e4236b0f38b8
Public Version Date
June 25, 2018
Public Version Number
1
DI Record Publish Date
May 23, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 120 |