Duns Number:388240673
Device Description: Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherite Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy
Catalog Number
OUBU15
Brand Name
Berichrom® a2-Antiplasmin
Version/Model Number
10446427
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
K884797
Product Code
GGP
Product Code Name
TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
Public Device Record Key
cd48277a-2cdc-4e40-b0cb-0aca1a8d2bb7
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 |