Duns Number:388240673
Device Description: For the determination of the activity of coagulation factor IX in human plasma by coagulom For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods
Catalog Number
OTXX17
Brand Name
Coagulation Factor IX Deficient Plasma
Version/Model Number
10446414
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
K924396,K924396
Product Code
GJT
Product Code Name
PLASMA, COAGULATION FACTOR DEFICIENT
Public Device Record Key
c51dd097-444b-4d7a-b7e0-5f1d2393ebe9
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 |