Duns Number:388240673
Device Description: Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems
Catalog Number
OSAZ15
Brand Name
N Antiserum to Human a1-Antitrypsin
Version/Model Number
10446312
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
K053072
Product Code
DEM
Product Code Name
ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
5d9723c7-7c49-4e6d-a350-d0ffa45f0df1
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 |