Duns Number:249373515
Device Description: A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.
Catalog Number
-
Brand Name
VisuCon-L(TM) Abnormal Control Plasma
Version/Model Number
LYABP01
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)
-
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
50d2f28c-3ef6-496d-92e3-6d2bd7e3ba9c
Public Version Date
October 30, 2019
Public Version Number
1
DI Record Publish Date
October 22, 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 | 2 |