Duns Number:249373515
Device Description: Intended for use in the quality control of coagulation assays in the borderline pathologic Intended for use in the quality control of coagulation assays in the borderline pathological range.
Catalog Number
-
Brand Name
VisuCon-F Frozen Abnormal Control Plasma
Version/Model Number
FRABP0125
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
K091284,K091284,K091284
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
1de009a5-a9ec-4554-ba08-2024a1941913
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 28, 2017
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 |