Duns Number:066761271
Device Description: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT.
Catalog Number
-
Brand Name
George King Pooled Normal Plasma
Version/Model Number
0010-1.5
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
c6580f9a-3790-4a57-b0eb-070e77ee74e3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 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. | 120 |