Duns Number:388240673
Device Description: Quantitative determination of plasminogen activity as an aid in the diagnosis and monitori Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
Catalog Number
OUCA17
Brand Name
Berichrom® Plasminogen
Version/Model Number
10446431
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
K884766
Product Code
DDX
Product Code Name
PLASMINOGEN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
7d1a5a7d-4fd0-4e46-92d0-0dad7402cf25
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 |