Duns Number:388240673
Device Description: Chromogenic assay for the automated quantitation of functionally active antithrombin in hu Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Catalog Number
OPFH07
Brand Name
INNOVANCE® Antithrombin
Version/Model Number
10487304
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
K081769
Product Code
JBQ
Product Code Name
ANTITHROMBIN III QUANTITATION
Public Device Record Key
bc50a7a0-7e26-4888-b7c7-f94cd7d41a0a
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 |