Duns Number:197934250
Device Description: For the quantitative determination of human coagulation factor XIII in plasma by immunotu For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.
Catalog Number
KAI-105
Brand Name
K-ASSAY® Factor XIII Reagent
Version/Model Number
KAI-105
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DBT
Product Code Name
Factor Xiii A, S, Antigen, Antiserum, Control
Public Device Record Key
fdde864e-b085-41a0-a0d3-71963e7464c4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |