Duns Number:388240673
Device Description: Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samp Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Catalog Number
B4233-25
Brand Name
Dade® Thrombin Reagent
Version/Model Number
10445720
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050928,K050928
Product Code
KQJ
Product Code Name
SYSTEM, FIBRINOGEN DETERMINATION
Public Device Record Key
7baf9ba8-ae5e-4826-9b45-e68435a5a8cc
Public Version Date
November 18, 2021
Public Version Number
5
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 |