Duns Number:079226220
Device Description: Alinity c A1-Antitrypsin Reagent Kit 200 Tests
Catalog Number
01R0721
Brand Name
Alinity
Version/Model Number
01R0721
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
K050596
Product Code
DEM
Product Code Name
ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
10573312-fd1d-4001-ae64-7cdef46109fc
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
January 04, 2019
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 | 259 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 245 |
| U | Unclassified | 5 |