Duns Number:079226220
Device Description: Alinity c ASO Reagent Kit 300 Tests
Catalog Number
01R0621
Brand Name
Alinity
Version/Model Number
01R0621
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
GTQ
Product Code Name
ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT
Public Device Record Key
6faca5f3-aeef-42d7-ba39-0446088c9489
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
January 02, 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 |