Duns Number:388240673
Device Description: Quantitative determination of fibrinogen in human plasma
Catalog Number
B4233-15SY
Brand Name
Dade® Fibrinogen Determination Reagents
Version/Model Number
10445718
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 12, 2018
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
-
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
GFK
Product Code Name
FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS
Public Device Record Key
6c2218e2-ecbe-4a41-a07e-dd74526f1a23
Public Version Date
November 18, 2021
Public Version Number
4
DI Record Publish Date
September 24, 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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |